{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3120-main", "verdict_number": "3120", "title": "Ordinary thiamine (vitamin B1); the question targets an oral single ingredient, with actual salt/product unverified × Reduction of 12-week HDRS total when added at SSRI initiation in adult MDD inpatients", "view_version": "1.0", "view_created_date": "2026-11-06", "criteria_version": "v3120-THIAMINE-MDD-HDRS12-1.1", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-16", "review_scope": { "materials_read": "Stored Korean and English manuscripts and case-specific criteria and application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Reading stored summaries is distinguished from not reading external source materials or historical separate documents, while preserving the original verdict, numerical values and unverified information. No new clinical search, source reading, effect calculation or reassessment was performed.", "date_meaning": "This is the date the stored materials were checked, not the date of an up-to-date clinical literature search." }, "claim_context": { "population": "Adult inpatients reported to have major depressive disorder (MDD) and baseline HDRS >24; diagnostic framework, age bounds and thiamine status unverified", "intervention": "Ordinary thiamine (vitamin B1); the question targets an oral single ingredient, with actual salt/product unverified · A single ingredient is the question target; the ordinary-thiamine salt and formulation are unverified in the original MDD report · The question targets oral administration; oral administration could not be verified in the accessed original MDD report", "dose": "Unverified from the original MDD report; no thiamine-equivalent dose calculated", "comparator": "Placebo + a newly initiated standardized SSRI in the candidate trial; exact drug, dose and other treatments unverified", "endpoint": "Clinician-rated HDRS total at 12 weeks; version, item count and score range unverified", "duration": "12 weeks (candidate trial endpoint; actual daily regimen unverified)", "excluded_extensions": [ "This page does not assess diagnosis, response/remission, relapse or suicide-related events. The need to correct deficiency is also separate from the efficacy of additional supplementation in thiamine-replete adults with depression; the candidate population is not presumed deficient or replete.", "Proceed as one independent table. Fix the question to adult MDD inpatients, addition at initiation of a new SSRI, and clinician-rated HDRS total at 12 weeks. Eligibility regarding actual oral administration, salt, single-ingredient composition and dose remains unverified in the original report. subclaims=[]; improvement at 6 weeks/within groups, remission/response, suicide prevention, deficiency correction, mood in healthy people, PCOS GHQ, observational studies/case reports, and combinations/fatigue are not pooled into the principal effect." ] }, "requirements": [ { "item_id": "N01", "question_type": "Claim and independent-question boundaries", "question": "Which adults, adjunctive treatment and 12-week outcome does this table address?", "needed": "Original claim, facets and subclaims, and clinical questions excluded from the same page", "role": "Required", "role_reason": "Needed to prevent the question about total depressive symptoms from shifting to general mood, remission or suicide prevention.", "application_exception": "Response, remission, relapse and suicide-related events remain separate questions rather than mandatory outcomes for this total-score question.", "criterion": "Link the original /ko/effect to the population, addition at SSRI initiation and HDRS at 12 weeks, and explain overlap between parent and subordinate questions.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M03 §3.2.4; custom boundaries on extensions", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should prespecify HDRS total at 12 weeks and response, remission and suicide-related events as separate outcomes.", "current_reports": [ "S01", "S03" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The original claim concerns treatment added at SSRI initiation in adult MDD inpatients and reduction of HDRS total at 12 weeks. The question is fixed to single-ingredient oral ordinary thiamine versus placebo, with subclaims=[]. Diagnosis, response/remission, relapse and suicide prevention are separate questions.", "condition_status": "Met", "status_reason": "The identity and exclusion boundaries of the independent question were linked to the retained original text. Meeting this condition does not mean that candidate-trial eligibility or treatment efficacy has been verified.", "missingness": "The question's identity is linked, but the actual product, route and effect remain separately unverified.", "uncertainty": "The question's identity is linked, but the actual product, route and effect remain separately unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original claim, facets and subclaims, and clinical questions excluded from the same page" }, { "item_id": "N02", "question_type": "Current source and identity", "question": "Do the current published source and this summary have the same identity?", "needed": "Current loader-selected path, original SHA, ID/canonical URL, version and actual publication receipt", "role": "Required", "role_reason": "Needed to avoid confusing historical wording about unassigned identifiers and nondeployment with the current ID/URL.", "application_exception": "Historical publication-readiness wording retained in KO is not deleted or reinterpreted as a site-publication event in this review.", "criterion": "Compare the current original and snapshot bytes, ID/canonical URL and reference date.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Record identities, dates and publication events separately by version, without creating new research results.", "current_reports": [], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The current ID is 3120 and the canonical path is /verdicts/mood/oral-thiamine-mdd-hdrs-12-weeks/. The current base original and inventory snapshot have the same 99,833 bytes and SHA. The needs_id_assignment/server-not-deployed wording in the KO summary_note is preserved as historical content and is not used as a deployment record for this summary conversion.", "condition_status": "Met", "status_reason": "The current record's identity was distinguished from historical status wording. The original site's current response or public availability was not checked in this review.", "missingness": "The production domain's response and actual deployment were not checked in this review.", "uncertainty": "The production domain's response and actual deployment were not checked in this review.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Current loader-selected path, original SHA, ID/canonical URL, version and actual publication receipt" }, { "item_id": "N03", "question_type": "Study and report families", "question": "Were the 21 reports kept from being counted repeatedly as unique trials?", "needed": "Original reports, figures, registrations, repositories, a family linkage table and unique-participant identity information", "role": "Required", "role_reason": "Needed to avoid counting figures, repositories, indexes and reviews for the same DOI as independent replications.", "application_exception": "Preserve the bibliography count, but do not estimate unresolved unique-study or participant counts or turn the three candidates into directly eligible trials.", "criterion": "Explain the roles of the S01 series as one family, S03 as a separate candidate and S04 as an indirect family.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future syntheses should first create study-level outcome tables after comparing registration numbers, authors, recruitment institutions, periods and participant overlap.", "current_reports": [ "S01", "S02", "S03", "S04", "S10", "S11", "S12", "S13", "S14" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01/S02/S10–S14 form one family, TF-GHALEIHA-2016. S03 is a different controlled study, TF-WATTANATHAMRAK-2019, but replication of the same comparison is unverified. S04 is TF-MOTI-2024 in PCOS/IVF and provides indirect material. The retained family table's 3 controlled candidates and 0 families eligible for efficacy grading are eligibility records from that time.", "condition_status": "Met", "status_reason": "Original report counts were distinguished from family roles, and no new count of directly eligible trials was established.", "missingness": "There is no new external verification of family identities, additional overlap or eligibility.", "uncertainty": "There is no new external verification of family identities, additional overlap or eligibility.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original reports, figures, registrations, repositories, a family linkage table and unique-participant identity information" }, { "item_id": "N04", "question_type": "Actual scope of reading", "question": "What was read in this review, and what was the historical level of access?", "needed": "Retained source/citation, access_level/date/locator, and actual files and reading events", "role": "Required", "role_reason": "Needed to avoid promoting the summary of the current stored summary to reading the original paper, figure or full text.", "application_exception": "Past failures, partial reading and reports of full-text access remain historical records; they are not reused as inaccessibility or full-text reading in this review.", "criterion": "Separate existence, access, acquisition, reading and current/historical dates for each material type.", "basis": "M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "When materials are acquired in the future, record the sections and tables actually read, file SHA and access events separately for each material type.", "current_reports": [ "S01", "S02", "S04", "S07", "S09", "S13", "S15" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The current stored summary for 3120 was read in this review, including its Korean text, structured evidence, 21 bibliographic records and historical access records. The records dated 2026-09-16 of partial access to S01, visual inspection of the S02 figure and access to the S04 HTML full text are history recorded in the original. External papers, figures, registrations and official materials were not accessed, acquired or read in this review; access was not attempted.", "condition_status": "Met", "status_reason": "Current actual actions were separated from historical records. Past PDF failures were not labeled as failures in this review, and historical full-text access to S04 was not labeled as current full-text reading.", "missingness": "External full texts and old separate ZIP files/logs were not opened in this review.", "uncertainty": "External full texts and old separate ZIP files/logs were not opened in this review.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Retained source/citation, access_level/date/locator, and actual files and reading events" }, { "item_id": "N05", "question_type": "Adult inpatient population", "question": "What are the candidate trial's population and baseline depression severity?", "needed": "Original eligibility criteria, age range, baseline tables by arm, inpatient setting and recruitment flow", "role": "Required", "role_reason": "Needed to avoid applying mood studies in healthy people or other diseases to adult MDD inpatients.", "application_exception": "Do not infer age ranges, arm composition or the status of all participants from mean age or the percentage of women.", "criterion": "Distinguish the reporting level and unverified details of MDD inpatient status, HDRS >24 and means/percentages.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Specify baseline severity and representativeness in the same inpatient MDD population and present balance between arms.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01 reports a total of 51 participants, all MDD inpatients, baseline HDRS >24, mean age 35.2 years and 53% women. Age bounds, sex distribution by arm and baseline scale means/variances are unverified. Do not turn means and percentages into identical characteristics of every adult.", "condition_status": "Partly verified", "status_reason": "The population label, setting and baseline threshold are preserved, but exact eligibility and balance between arms remain unknown.", "missingness": "Age range, inclusion/exclusion criteria, baseline distributions by arm and baseline means/SDs are unverified.", "uncertainty": "Age range, inclusion/exclusion criteria, baseline distributions by arm and baseline means/SDs are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original eligibility criteria, age range, baseline tables by arm, inpatient setting and recruitment flow" }, { "item_id": "N06", "question_type": "Diagnosis and special populations", "question": "Have the MDD diagnostic framework, episode, treatment resistance and major exclusions been verified?", "needed": "Original diagnostic interview/DSM/ICD, episode/resistance definitions, exclusion criteria and baseline tables by population", "role": "Required", "role_reason": "Needed to avoid interpreting the reported MDD label as verification of a specific diagnostic procedure, treatment resistance or exclusion of bipolar disorder.", "application_exception": "Do not fill in unverified exclusions, such as pregnancy, bipolar disorder or renal/liver disease, as if they had already been applied.", "criterion": "Link diagnosis, episode, treatment resistance, comorbidities and the scope of exclusions to the original methods.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Prespecify diagnostic procedures and episode/resistance criteria, and analyze applicability to special populations separately.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The retained manuscript confirms that MDD was reported, but the DSM/ICD version, diagnostic interview, episode status and treatment resistance are unverified. Exclusions and population composition regarding pregnancy/lactation, bipolar disorder, dementia/delirium, renal/liver status and comorbidities are also unverified.", "condition_status": "Unverified", "status_reason": "The retained location read explicitly describes a gap in access to the original methods, so the exact diagnostic and exclusion conditions cannot be said to have been met.", "missingness": "Diagnosis and exclusions are gaps in the accessed portions of the original report. Do not conclude that they are unreported throughout the original paper.", "uncertainty": "Diagnosis and exclusions are gaps in the accessed portions of the original report. Do not conclude that they are unreported throughout the original paper.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original diagnostic interview/DSM/ICD, episode/resistance definitions, exclusion criteria and baseline tables by population" }, { "item_id": "N07", "question_type": "Deficiency, nutrition and alcohol use", "question": "Was the candidate population thiamine-deficient or thiamine-replete?", "needed": "Original baseline thiamine tests/deficiency criteria, dietary/nutritional/alcohol-use records and the review's original citation location", "role": "Required", "role_reason": "Needed to avoid combining correction of deficiency with the effect of additional supplementation in a replete state.", "application_exception": "Do not use the secondary (2nd) review's word deficient to establish the original report's testing, deficiency threshold or replete status.", "criterion": "Separate baseline thiamine markers/thresholds, meals, nutrition and alcohol use from the verification level of secondary (2nd) statements.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should measure baseline status and assess interaction by prespecified deficiency status.", "current_reports": [ "S01", "S08" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S08's secondary (2nd) narrative calls the S01 population thiamine-deficient. Neither deficiency nor repletion was verified in the accessed S01 original, and baseline markers, thresholds, nutrition, diet and alcohol use are unverified. This conflict concerns the level of verification of deficiency status, not conflicting numerical clinical effects.", "condition_status": "Conflicting information", "status_reason": "The secondary (2nd) assertion and the original-report verification gap were preserved, without arbitrarily adopting either status.", "missingness": "Original tests/criteria and arm-level data needed to determine baseline status are unverified.", "uncertainty": "Original tests/criteria and arm-level data needed to determine baseline status are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original baseline thiamine tests/deficiency criteria, dietary/nutritional/alcohol-use records and the review's original citation location" }, { "item_id": "N08", "question_type": "Molecule and single-ingredient composition", "question": "Can ordinary thiamine be distinguished from the actual salt and single-ingredient product?", "needed": "Original trial product name, salt, active/added ingredients, manufacturing/formulation documents and administration records", "role": "Required", "role_reason": "Needed to avoid assigning the identity of derivatives, combinations or other products to the candidate trial.", "application_exception": "Derivatives such as benfotiamine and TTFD, combinations and injections are excluded from the question, but the candidate product is not presumed to have been a single-ingredient preparation.", "criterion": "Show separately the question target and the level of verification of the actual label, salt, source and composition in the original report.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future direct comparisons should predefine and disclose the salt, product and composition of ordinary thiamine and the control product.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The question targets single-ingredient oral ordinary thiamine. S01 reports the ingredient name thiamine (vitamin B1), but the exact salt, product, source and single-ingredient composition could not be verified. Benfotiamine, fursultiamine/TTFD, sulbutiamine, allithiamine, phosphorylated derivatives, combinations and injections are not direct evidence for the same question.", "condition_status": "Unverified", "status_reason": "The general ingredient name alone is not treated as meeting eligibility requirements for the exact molecule/salt and single-ingredient composition.", "missingness": "The candidate trial's product identity and actual composition are unverified.", "uncertainty": "The candidate trial's product identity and actual composition are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original trial product name, salt, active/added ingredients, manufacturing/formulation documents and administration records" }, { "item_id": "N09", "question_type": "Actual route of administration", "question": "Was oral administration verified in the candidate MDD original report?", "needed": "Actual route of administration, product and prescription records in the candidate original report's Methods", "role": "Required", "role_reason": "Needed to avoid turning an oral-administration question into a fact of actual oral administration.", "application_exception": "The review's oral-administration information is a lead for tracing the original report, not verification of the route in that report.", "criterion": "Distinguish the actual route in the original report from the question's route, and link the route-verification gap to its location.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future comparisons should document oral administration and actual intake, and separate these from injection and derivative data.", "current_reports": [ "S01", "S04", "S07" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The question concerns oral administration, but the actual oral route was not verified in retained S01. Oral-administration information in the S07 review is not a route verified in the original report, and oral-administration information in the PCOS study S04 does not establish the route in S01 either.", "condition_status": "Unverified", "status_reason": "The current eligibility gap in the original report was maintained. An unverified oral route does not mean that a parenteral route has been verified.", "missingness": "The original Methods needed to verify the actual route in S01 remain unverified.", "uncertainty": "The original Methods needed to verify the actual route in S01 remain unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual route of administration, product and prescription records in the candidate original report's Methods" }, { "item_id": "N10", "question_type": "Dose, intake and adherence", "question": "Have the actual prescribed dose and administration regimen in S01 been verified?", "needed": "S01 original prescription/product, daily and per-administration doses, frequency, meal timing, adherence records and handling of deviations", "role": "Required", "role_reason": "Needed to avoid transferring 300 mg/day from another study or review into a verified dose for the candidate trial.", "application_exception": "Do not arbitrarily convert hydrochloride mg or thiamine-equivalent amounts, or fill in unverified frequency, meal timing or adherence.", "criterion": "Distinguish daily/per-administration doses, frequency, meal timing, loading/maintenance and adherence from study duration.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should record actual intake, adherence and changes, and assess dose optimization in separate direct comparisons.", "current_reports": [ "S01", "S03", "S04", "S07" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "Daily dose, per-administration dose, frequency, meal timing, loading/maintenance and adherence are unverified from the S01 original. The S07 information on oral 300 mg/day and fluoxetine 20 mg/day is not verified in the original report. For S03 and S04, 300 mg/day is also retained only as the nominal dose in each separate study.", "condition_status": "Unverified", "status_reason": "Although the 12-week endpoint is preserved, the actual daily prescription and exposure cannot be established.", "missingness": "S01 dose/conversion, actual exposure and adherence data are unverified.", "uncertainty": "S01 dose/conversion, actual exposure and adherence data are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S01 original prescription/product, daily and per-administration doses, frequency, meal timing, adherence records and handling of deviations" }, { "item_id": "N11", "question_type": "Incremental effect at SSRI initiation", "question": "Is this an adjunctive-treatment comparison at initiation of a new SSRI?", "needed": "Records of SSRI initiation timing, drug/dose, maintenance at therapeutic levels and added ingredient/placebo in both arms", "role": "Required", "role_reason": "Needed to avoid turning improvement from the SSRI itself into thiamine monotherapy efficacy or augmentation of a stable dose.", "application_exception": "Newly initiated standard treatment and stable pre-existing treatment are not automatically pooled as the same incremental effect.", "criterion": "Preserve actual background-treatment initiation and maintenance and the structure of the placebo add-on comparison.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Compare only the added ingredient on top of the same SSRI initiation, and design augmentation of a stable dose as a separate stratum.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01 reports a comparison of added thiamine or placebo while a standardized SSRI was newly initiated and maintained at therapeutic levels. It is not verified as a trial of thiamine monotherapy or augmentation of a stable pre-existing antidepressant dose. The SSRI name, dose and actual treatment by arm are unverified.", "condition_status": "Partly verified", "status_reason": "The adjunctive comparison's structure is preserved, but the specific identity of the shared treatment and its implementation by arm remain unknown.", "missingness": "Drug, dose and arm-level treatment changes and maintenance data are unverified.", "uncertainty": "Drug, dose and arm-level treatment changes and maintenance data are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Records of SSRI initiation timing, drug/dose, maintenance at therapeutic levels and added ingredient/placebo in both arms" }, { "item_id": "N12", "question_type": "Placebo and other treatments", "question": "How were placebo, psychotherapy, other drugs and rescue treatment compared?", "needed": "Placebo composition/appearance, psychotherapy/other psychotropics by arm, rescue treatment and records of changes", "role": "Required", "role_reason": "Needed to avoid mixing differences in concomitant treatment with the selected ingredient's contribution.", "application_exception": "Do not assume that all changes must be identical; examine the actual effect of interest and how changes by arm were handled.", "criterion": "Distinguish the placebo label from actual matching, shared treatment and rescue treatment/psychotherapy by arm.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Adjunctive comparisons should disclose concomitant treatment and rescue use by arm and handle these in a predefined analysis.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The control treatment in S01 is placebo, and the shared treatment is a newly initiated standardized SSRI. Placebo composition/appearance and actual treatment by arm, including psychotherapy, other psychotropics and rescue treatment, are unverified because of the gap in access to the original methods.", "condition_status": "Partly verified", "status_reason": "A placebo comparison was reported, but specific verification of what was the same or different apart from the added ingredient remains outstanding.", "missingness": "Placebo matching, concomitant treatment/changes by arm, rescue treatment and their analytical handling are unverified.", "uncertainty": "Placebo matching, concomitant treatment/changes by arm, rescue treatment and their analytical handling are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Placebo composition/appearance, psychotherapy/other psychotropics by arm, rescue treatment and records of changes" }, { "item_id": "N13", "question_type": "Allocation and design", "question": "Have the implementation of randomization, allocation concealment and baseline balance been verified?", "needed": "Sequence generation, concealment, unit of allocation, baseline tables by arm and participant flow in the original Methods", "role": "Required", "role_reason": "Needed to avoid stating that allocation issues were resolved merely from the randomized label.", "application_exception": "Do not turn unverified design details into an unsupported Not applicable designation for crossover/cluster considerations.", "criterion": "Link the reported randomized placebo comparison to gaps concerning actual sequence generation, concealment and allocation/baseline details.", "basis": "M08 §8.1–8.2.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future trials should predefine allocation and concealment and disclose participant flow and baseline data by arm.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01 is reported as a randomized thiamine-versus-placebo trial. The full methods section needed to verify sequence generation, concealment, unit of allocation and baseline balance by arm was not acquired within the current retained scope.", "condition_status": "Partly verified", "status_reason": "The comparative design is named, but evidence verifying actual allocation is insufficient.", "missingness": "Sequence generation, concealment, unit of allocation and baseline balance are unverified.", "uncertainty": "Sequence generation, concealment, unit of allocation and baseline balance are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Sequence generation, concealment, unit of allocation, baseline tables by arm and participant flow in the original Methods" }, { "item_id": "N14", "question_type": "Blinding and assessment implementation", "question": "Have assessor blinding and the actual HDRS measurement procedure been verified?", "needed": "Original blinding, unblinding/verification, assessor training/agreement and measurement procedures by arm", "role": "Required", "role_reason": "Needed to distinguish differences in the implementation of clinician assessment from actual differences in symptoms.", "application_exception": "A bibliographic title stating double blind does not establish successful blinding of every party or successful implementation of all assessment procedures.", "criterion": "Link assessor and participant/treatment blinding, timing, training and assessment agreement to the actual methods.", "basis": "M08 Table 8.2.a, M03 §3.2.4; custom application; M08 §8.1–8.2.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Define independent assessment procedures using the same scale and time point, and record measurement differences between arms.", "current_reports": [ "S01", "S13" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The HDRS in S01 is retained as a clinician/expert assessment. The bibliographic URL for S13 contains double_blind, but actual implementation of assessor blinding, scale training, agreement and any unblinding are unverified. Do not conclude that measurement bias is absent from the title or URL alone.", "condition_status": "Unverified", "status_reason": "The assessor type is recorded, but implementation of blinding and measurement consistency for the selected outcome remain unknown.", "missingness": "Assessment blinding, training, agreement and verification of implementation are unverified.", "uncertainty": "Assessment blinding, training, agreement and verification of implementation are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original blinding, unblinding/verification, assessor training/agreement and measurement procedures by arm" }, { "item_id": "N15", "question_type": "51 participants and analysis denominators", "question": "Were the total of 51 participants and arm-level randomized, analyzed and completed counts distinguished?", "needed": "Original CONSORT and allocation/completion/withdrawal tables, the HDRS analysis population at 12 weeks and n by arm", "role": "Required", "role_reason": "Needed to avoid turning the abstract's total participant count into the actual analysis denominator at 12 weeks.", "application_exception": "Do not split the odd total participant count between arms or add it to S03 and S04.", "criterion": "Show the label for the reported total count and the unverified arm-level allocation/completion/analysis and principal-time-point denominators.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Present the full flow by arm and the analysis n for each outcome, and examine the link between outcomes and attrition.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "In S01, the 51 participants are the total reported in the abstract. Arm-level randomized, analyzed and completed n and the number analyzed for HDRS at 12 weeks are unverified. Do not divide the 51 participants into two arms or use them as the safety denominator at 12 weeks.", "condition_status": "Partly verified", "status_reason": "The reported total is preserved, but the arm-level analysis denominators for the outcome of interest cannot be verified.", "missingness": "Arm-level randomized, analyzed and completed counts and measurement/exposure n at 12 weeks are unverified.", "uncertainty": "Arm-level randomized, analyzed and completed counts and measurement/exposure n at 12 weeks are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original CONSORT and allocation/completion/withdrawal tables, the HDRS analysis population at 12 weeks and n by arm" }, { "item_id": "N16", "question_type": "Missing data and analysis populations", "question": "Have attrition, missing data, ITT/PP and the effect analyzed been verified?", "needed": "Original missingness/attrition by arm at 12 weeks, analysis n, SAP, ITT/PP and sensitivity results", "role": "Required", "role_reason": "Needed to identify the material required to examine whether selection of completers/analyzed participants changes the between-group result.", "application_exception": "If the original material does not specify the analysis, do not arbitrarily fill in ITT, PP, LOCF or another method.", "criterion": "Distinguish reasons for attrition, missing data by arm, their handling, analysis populations and the effect of interest.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Prespecify the distinction between the effect of assignment and the effect of adherence, and present missing-data assumptions and sensitivity analyses.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The analysis n by arm, reasons for attrition/missingness, missing-data handling and ITT/PP analysis populations in S01 are unverified. Whether the analysis was adjusted or unadjusted, and whether the effect of interest concerns final values or changes, are also unresolved.", "condition_status": "Unverified", "status_reason": "Even the same between-group difference can be interpreted differently depending on the analysis population and missing-data handling, so no analysis label was invented to fill the gap.", "missingness": "Missing data/attrition, analysis methods, models and the estimand are unverified.", "uncertainty": "Missing data/attrition, analysis methods, models and the estimand are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original missingness/attrition by arm at 12 weeks, analysis n, SAP, ITT/PP and sensitivity results" }, { "item_id": "N17", "question_type": "HDRS version and total score", "question": "What are the actual HDRS version, items, range and direction?", "needed": "Original scale version, items/range, scoring instructions and assessment result tables by arm", "role": "Required", "role_reason": "Needed to avoid treating other depression scales or individual items as the same effect as HDRS total.", "application_exception": "Do not infer 17/21 items or a score range from the HDRS label, or substitute a GHQ subscale.", "criterion": "Separate the recorded clinician-rated total and lower-is-better direction from the unverified version/items/range.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom boundaries on extensions", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future trials should prespecify the exact scale, version, total score and assessor procedures.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The selected outcome is the continuous depression total on the clinician-rated Hamilton Depression Rating Scale, with lower scores indicating improvement. The actual version, item count and score range are unverified. The GHQ-28 depression subscale with 7 items and individual sleep/appetite items are not the same total score.", "condition_status": "Partly verified", "status_reason": "The scale name, construct and direction are preserved, but the version and range needed to interpret the actual score units remain unknown.", "missingness": "Version, item count, score range and actual scoring procedures are unverified.", "uncertainty": "Version, item count, score range and actual scoring procedures are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original scale version, items/range, scoring instructions and assessment result tables by arm" }, { "item_id": "N18", "question_type": "12 weeks and intermediate visits", "question": "Were the endpoint result at 12 weeks and signals at 3 and 6 weeks distinguished?", "needed": "Original visit schedule, principal time point in the registration/protocol, result tables by time and actual prescribed exposure", "role": "Required", "role_reason": "Needed to avoid substituting a favorable intermediate time point for the selected 12-week question.", "application_exception": "Do not describe the current manuscript's choice of 12 weeks as trial preregistration, or infer the actual daily prescription.", "criterion": "Link the reported 0, 3, 6 and 12 weeks to the manuscript's chosen principal time point and its prespecification status.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M08 Table 8.2.a, M04 §4.6.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future comparisons should prespecify the principal time point and repeated-measurement plan and disclose all intermediate results.", "current_reports": [ "S01", "S02" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The visits in retained S01 are at 0, 3, 6 and 12 weeks, and this table's principal time point is 12 weeks. The choice of principal time point is recorded as a review choice in the current manuscript, not as verified trial preregistration. The favorable signal at 6 weeks is preserved but does not replace the result at 12 weeks.", "condition_status": "Met", "status_reason": "The roles of the time points were distinguished. Meeting this condition is separate from verification of the effect/prescribed dose at 12 weeks.", "missingness": "The trial's prespecified outcome hierarchy and actual administration exposure are unverified.", "uncertainty": "The trial's prespecified outcome hierarchy and actual administration exposure are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original visit schedule, principal time point in the registration/protocol, result tables by time and actual prescribed exposure" }, { "item_id": "N19", "question_type": "Between-group effects, within-group changes and the original effect", "question": "Has the exact estimate of the between-group effect at 12 weeks been verified?", "needed": "Original arm-level total scores/changes at 12 weeks, adjusted/unadjusted between-group estimates and analysis definitions", "role": "Required", "role_reason": "Needed to avoid turning within-group improvement in both arms into thiamine's incremental contribution.", "application_exception": "Do not reconstruct numerical values from the figure or use the 6-week result or response/remission P values to fill in the total-score result at 12 weeks.", "criterion": "Distinguish the between-group mean difference at 12 weeks from final values/changes and within-group improvement.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Directly estimate the predefined incremental effect at 12 weeks between groups, and present within-group changes separately.", "current_reports": [ "S01", "S02" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01/S02 report a favorable signal at 6 weeks, a nonsignificant between-group mean difference at 12 weeks and improvement in both groups. The exact between-group difference at 12 weeks, arm means, changes and adjustment status are unverified. Within-group improvement does not establish a causal effect of thiamine.", "condition_status": "Unverified", "status_reason": "The numerical estimate of interest and its analysis definition are missing, so the magnitude of the incremental effect cannot be established.", "missingness": "The exact effect at 12 weeks, final values/changes, model and arm-level numerical values are unverified.", "uncertainty": "The exact effect at 12 weeks, final values/changes, model and arm-level numerical values are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original arm-level total scores/changes at 12 weeks, adjusted/unadjusted between-group estimates and analysis definitions" }, { "item_id": "N20", "question_type": "Variability, CI and graph", "question": "Can the SD/SE and confidence interval at 12 weeks be interpreted?", "needed": "Original numerical tables at 12 weeks, SD/SE definitions, analysis n by arm, CI and model output", "role": "Required", "role_reason": "Needed to avoid arbitrarily deriving precision from graph bars or sample size.", "application_exception": "Do not use qualitative inspection of the original Fig.1 as digitization or reconstruction of SD/SE or CI.", "criterion": "Show the actual meaning of the reported variability and intervals and the scope of missing values.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Report uncertainty intervals together with the variability/denominators used, and disclose the source data for the figure.", "current_reports": [ "S01", "S02" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The retained record explicitly states that Figure 1 was inspected only qualitatively and that graph digitization, arm means, SD/SE and effect/CI were not reconstructed. The confidence interval at 12 weeks and type of variability measure are unverified. The figure's S/S/L/M labels are not a verified MCID either.", "condition_status": "Unverified", "status_reason": "Without exact variability and intervals, it cannot be determined whether important benefit or harm has been excluded.", "missingness": "SD/SE, n by arm, CI and MCID are unverified, and no new calculation is performed.", "uncertainty": "SD/SE, n by arm, CI and MCID are unverified, and no new calculation is performed.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original numerical tables at 12 weeks, SD/SE definitions, analysis n by arm, CI and model output" }, { "item_id": "N21", "question_type": "Exact P value and importance", "question": "Have the P value at 12 weeks and the criterion for a clinically important difference been verified?", "needed": "Original exact P value, CI and effect at 12 weeks, and evidence for an important difference appropriate to the HDRS version/population", "role": "Required", "role_reason": "Needed to avoid declaring sufficient effect or precision from significance or participant counts alone.", "application_exception": "Do not fill in unverified P values or MCIDs using conventional thresholds or P values for other outcomes.", "criterion": "Explain whether the exact P value and CI at 12 weeks can be compared with an evidence-based important difference.", "basis": "M15 §15.3.1–15.3.3; custom application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should justify the important difference with evidence and disclose the range of effects allowed by the CI.", "current_reports": [ "S01", "S02", "S07" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The exact P value at 12 weeks and MCID are retained as unverified (null). Only a statement of nonsignificance is available; without an interval, clinically important benefit cannot be excluded. The response/remission P values in S07 are not P values for total-score severity.", "condition_status": "Unverified", "status_reason": "The effect, interval and scale criterion needed to judge importance are all missing.", "missingness": "The exact P value, CI, MCID and evidence establishing clinical_importance are unverified.", "uncertainty": "The exact P value, CI, MCID and evidence establishing clinical_importance are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original exact P value, CI and effect at 12 weeks, and evidence for an important difference appropriate to the HDRS version/population" }, { "item_id": "N22", "question_type": "Preserving nonsignificant and positive findings", "question": "Were favorable findings and statements of no difference both retained without exaggeration?", "needed": "All results by time, corrections, analysis definitions and exact original numerical tables", "role": "Required", "role_reason": "Needed to avoid selecting only improvement at 6 weeks to erase the 12-week gap, or turning nonsignificance into an effect of 0.", "application_exception": "Positive findings at other time points, in other populations or on other scales are not automatically treated as conflicts or replications.", "criterion": "Preserve the signal at 6 weeks, nonsignificance at 12 weeks, within-group improvement and positive findings in other studies with their original attribution.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should report all favorable/nonsignificant/unfavorable results according to prespecified time points and analyses.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The favorable signal at 6 weeks, the nonsignificant between-group result at 12 weeks and within-group improvement in both arms were all preserved. The different controlled comparison in S03 and the indirect positive result in S04 are also retained separately. Nonsignificance does not mean an effect of 0, equivalence, noninferiority or exclusion of important benefit.", "condition_status": "Met", "status_reason": "The direction and applicability of the current reports were explained, without arbitrarily selecting only favorable findings.", "missingness": "Exact numerical values, intervals and direct eligibility remain unverified.", "uncertainty": "Exact numerical values, intervals and direct eligibility remain unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "All results by time, corrections, analysis definitions and exact original numerical tables" }, { "item_id": "N23", "question_type": "Funding, product provision and COI", "question": "To what level of disclosure has independence been verified?", "needed": "Original funding, internal support, product provision, employee/patent relationships, declared COI and declarations in each report", "role": "Supplementary; required for claims of independence", "role_reason": "Needed to avoid turning unverified funding or a declaration of no external funding into complete independence.", "application_exception": "Do not automatically exclude results because funding/COI exists, or conclude that bias is absent because it does not.", "criterion": "Attribute separately the declarations and internal-support/product gaps in S01, unverified details in S03 and funding in S04.", "basis": "Chamgap's own independence and attribution conditions. The official methodological sections used in this pilot do not validate all details of this item; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should disclose public, institutional and product support and author relationships item by item, and distinguish them from independent replication.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S01 declares no external funding and no author conflicts, but internal support and product provision are unverified. Funding, product provision and COI in S03 are unverified. For S04, the IUMS grant 94-04-28-26840, support from the Sarem research center and the declaration of no COI are preserved.", "condition_status": "Partly verified", "status_reason": "Declarations were distinguished from actual verification gaps, and funding from another family was not assigned to the candidate trial.", "missingness": "Internal support/product provision and employment/patents in S01 remain incompletely verified, and funding/COI information in S03 remains unverified.", "uncertainty": "Internal support/product provision and employment/patents in S01 remain incompletely verified, and funding/COI information in S03 remains unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original funding, internal support, product provision, employee/patent relationships, declared COI and declarations in each report" }, { "item_id": "N24", "question_type": "Registration, selective reporting and integrity", "question": "Were the original registration, outcome hierarchy, corrections and scope of unverified information compared?", "needed": "Original registration ID, prospective timing, protocol/SAP, outcome changes, correction/retraction notices and actual access events", "role": "Required", "role_reason": "Needed to avoid turning failure to obtain a registration into confirmed nonregistration or selective reporting, or a guarantee of no retraction.", "application_exception": "Do not retrospectively relabel the current manuscript's principal-time-point selection or historical targeted searches as preregistration or a complete, up-to-date integrity check.", "criterion": "Distinguish the registration/plan gap for S01 from the scope of the correction search at that time.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future research should compare plans and results by version and record reasons for changes and unreported outcomes.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The registration identifier, timing and prespecified outcome hierarchy for S01 were not verified. A record states that no correction, retraction or expression of concern was found on the publisher page opened or in targeted searches at that time, but this is not an exhaustive integrity guarantee. There is no new registration or publication-status lookup in this review.", "condition_status": "Unverified", "status_reason": "Without the original registration/protocol needed to compare plans and results, selective reporting is not determined.", "missingness": "S01 registration/plans/timing and current publication status are unverified.", "uncertainty": "S01 registration/plans/timing and current publication status are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original registration ID, prospective timing, protocol/SAP, outcome changes, correction/retraction notices and actual access events" }, { "item_id": "N25", "question_type": "Secondary (2nd) formulation and dose leads", "question": "What is the evidential level of the oral-administration, dose and SSRI information in the S07 review?", "needed": "Relevant S07 tables/sections and original citations, and the S01 product, route, daily dose and scale Methods", "role": "Required", "role_reason": "Needed to prevent secondary (2nd) information from automatically resolving original-report eligibility gaps.", "application_exception": "The review's tables and descriptions are leads for tracing the original report, not direct verification of the S01 product/route/dose.", "criterion": "Keep the secondary (2nd) information on oral 300 mg/day, fluoxetine 20 mg/day and unspecified formulation distinct as recorded.", "basis": "M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future material reviews should link each secondary (2nd) claim to a precise location in the original report and compare agreement.", "current_reports": [ "S01", "S07" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S07 provides leads of oral 300 mg/day and fluoxetine 20 mg/day while recording that the formulation was not specified. Only selected portions of PDF pages 4–6 were inspected at that time; this is not a record of reading all other pages. Do not promote this information to verified route, product, dose or version values from the S01 original.", "condition_status": "Partly verified", "status_reason": "Tracing leads exist, but the original Methods needed for direct verification remain outstanding.", "missingness": "Comparison of the review's leads with the original report and the actual formulation/product and dose in S01 remain unverified.", "uncertainty": "Comparison of the review's leads with the original report and the actual formulation/product and dose in S01 remain unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Relevant S07 tables/sections and original citations, and the S01 product, route, daily dose and scale Methods" }, { "item_id": "N26", "question_type": "A separate controlled MDD signal", "question": "In S03, do the 50 participants, 300 mg/day and P values represent the same 12-week effect?", "needed": "Full S03 Methods/results, n by arm, route/salt, principal time point, analysis attribution of each P value and SSRI/placebo information", "role": "Required", "role_reason": "Needed to avoid combining another controlled MDD study as an exact replication of the placebo comparison at SSRI initiation and 12 weeks.", "application_exception": "Do not arbitrarily assign P=.004/.031/.035 to particular visits, analyses or 12 weeks.", "criterion": "Link the actual S03 population, standard-treatment control, HRSD and denominator/time-point gaps.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future syntheses should compare studies after verifying exact PICOT agreement and visit-specific estimates, without automatically creating an average.", "current_reports": [ "S03" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S03 studied 50 participants, adults with MDD aged 18–60 years in inpatient/outpatient care, adding thiamine 300 mg/day to standard treatment. It reports allocation by drawing lots and improvement in HRSD; the P-value sequence is .004, .031, .035, but the exact visits and effects of interest for the later values are unverified. Oral route, salt, single-ingredient composition, duration, scale version, n by arm and the placebo-controlled effect at 12 weeks were not verified.", "condition_status": "Partly verified", "status_reason": "The other controlled signal is preserved, but the dimensions needed to verify direct comparability with the selected question are insufficient.", "missingness": "The visit/analysis for each P value, the original effect at 12 weeks, CI, exact route/composition and treatment by arm are unverified.", "uncertainty": "The visit/analysis for each P value, the original effect at 12 weeks, CI, exact route/composition and treatment by arm are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Full S03 Methods/results, n by arm, route/salt, principal time point, analysis attribution of each P value and SSRI/placebo information" }, { "item_id": "N27", "question_type": "S03 publication-identity conflict", "question": "Are the date, issue and citation year for S03 consistent?", "needed": "The journal's canonical metadata, corrections to date/issue/citation information and publication events by version", "role": "Supplementary; required for bibliographic identity", "role_reason": "Needed to avoid changing the original record by overwriting different bibliographic years with a single value.", "application_exception": "Do not extend a bibliographic date conflict to a conflict in the clinical results or the entire treatment duration.", "criterion": "Preserve all of the published date 2019-09-24, the 2020 issue and the 2019 citation year.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Record changes in bibliographic identity together with the original values; this is not an efficacy experiment.", "current_reports": [ "S03" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The publication-date field for S03 is 2019-09-24, the volume/issue is Vol.36 No.1 (2020), and the citation year is 2019. The original record preserves all these fields without inventing a resolution. The two PDF links could not be accessed at that time, and the original PDF was not read in this review either.", "condition_status": "Conflicting information", "status_reason": "Because publication details differ within the same report, Conflicting information is retained only for the bibliographic scope.", "missingness": "The meaning of the dates in the canonical metadata and the correspondence between corrections/versions are unverified.", "uncertainty": "The meaning of the dates in the canonical metadata and the correspondence between corrections/versions are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The journal's canonical metadata, corrections to date/issue/citation information and publication events by version" }, { "item_id": "N28", "question_type": "Indirect PCOS/IVF population", "question": "Is S04 a direct result for MDD inpatients at SSRI initiation?", "needed": "Actual S04 eligibility, scale, duration, product, depression-subgroup data and original plan", "role": "Required", "role_reason": "Needed to avoid transferring results for other populations, scales or time points to the selected effect merely because the trial used oral B1.", "application_exception": "Retain the indirect study's original data, but do not turn exclusion of psychological disorders and the absence of a depression entry threshold into an MDD sample.", "criterion": "Show the difference between PCOS/IVF at ages 18–40 years with GHQ at 4 weeks and MDD with HDRS at 12 weeks.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "To answer the MDD question, separately design a direct comparison in the same MDD/SSRI-initiation setting with HDRS at 12 weeks.", "current_reports": [ "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S04 is a trial in women with PCOS, infertility and IVF, aged 18–40 years, using oral thiamine for 4 weeks at 300 mg/day. It excluded diagnosed psychological disorders and did not require a depression entry threshold. The GHQ-28 depression subscale with 7 items and a 0–21 range differs from HDRS total at 12 weeks in adult MDD inpatients.", "condition_status": "Met", "status_reason": "The indirect role and reasons for exclusion were clearly linked. Oral-administration information and the product manufacturer in S04 do not establish the identity of S01.", "missingness": "Direct results matching the selected MDD question and an MDD subgroup effect are unverified.", "uncertainty": "Direct results matching the selected MDD question and an MDD subgroup effect are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual S04 eligibility, scale, duration, product, depression-subgroup data and original plan" }, { "item_id": "N29", "question_type": "PCOS denominators, numerical values and SD", "question": "Were S04 denominators and positive results correctly attributed?", "needed": "S04 original Tables 2–3, CONSORT, analysis n, actual depression-subgroup results and missing-data handling", "role": "Supplementary; required for describing indirect results", "role_reason": "Needed to avoid confusing the 70 participants randomized with the 64 participants analyzed, or SD with total-score/subgroup results.", "application_exception": "Do not convert means on another scale into an HDRS effect or calculate new between-group differences/changes.", "criterion": "Separately preserve the 35/35 randomized and 32/32 analyzed counts and the original GHQ means/SDs and P value.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Indirect studies should separate overall/subgroup populations and randomized/completed counts, and present scale-specific estimates and intervals.", "current_reports": [ "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S04 randomized 35/35 participants, with 32/32 participants analyzed/completed. GHQ depression-subscale means (SDs) were 16.46 (SD 4.98) versus 15.84 (SD 5.53) at baseline and, at 4 weeks, 10.96 (SD 4.93) versus 16.25 (SD 4.87), with reported between-group P < .001. Baseline depression-domain scores ≥6 are retained as 30/28 participants, with a total of 6 participants below the threshold; the eligible depression-subgroup effect is unverified (null).", "condition_status": "Partly verified", "status_reason": "The original numerical values, SDs and denominators are linked, but they are not the selected MDD effect or a direct comparison in the relevant subgroup.", "missingness": "Subgroup effects, re-extraction of CONSORT events, intervals/missing data and direct comparison of the multiple-domain analysis remain outstanding.", "uncertainty": "Subgroup effects, re-extraction of CONSORT events, intervals/missing data and direct comparison of the multiple-domain analysis remain outstanding.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S04 original Tables 2–3, CONSORT, analysis n, actual depression-subgroup results and missing-data handling" }, { "item_id": "N30", "question_type": "S04 reporting and plan gaps", "question": "How were S04 thresholds, percentages, outcome hierarchy and registration retained?", "needed": "S04 table/text corrections, protocol, original IRCT registration/versions, CONSORT and raw data", "role": "Supplementary; required for accuracy of indirect material", "role_reason": "Needed to avoid resolving original reporting inconsistencies and failure to obtain registration in a favorable direction.", "application_exception": "Do not silently correct original percentages or infer prospective timing from the digits in the IRCT identifier.", "criterion": "Preserve historical quality notes, gaps in the original registration record and differences in scale thresholds/hierarchy.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future material comparisons should disclose the original definitions of thresholds, denominators and hierarchy and reasons for changes, and check sensitivity.", "current_reports": [ "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "In S04, the abnormal threshold >6 in the text differs from Table 2's ≥6 notation. The retained note records that the printed percentages for 6/32 and 26/32 appear arithmetically inconsistent, but the original values are not silently corrected. Differences in wording about the general-health/infertility outcome hierarchy between the abstract and Methods also remain, and the original IRCT201510266917N3 registration and prospective timing are unverified.", "condition_status": "Conflicting information", "status_reason": "The current conflicts are limited to the thresholds, reporting and hierarchy recorded in the retained manuscript. The table was not recalculated and the original registration was not checked in this review.", "missingness": "Actual comparison of the original tables/plans, corrections and registration timing remains unverified.", "uncertainty": "Actual comparison of the original tables/plans, corrections and registration timing remains unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S04 table/text corrections, protocol, original IRCT registration/versions, CONSORT and raw data" }, { "item_id": "N31", "question_type": "Healthy participants, observational studies and deficiency case reports", "question": "Do the results in S16–18 directly answer the selected adjunctive-efficacy question?", "needed": "Population, design, exposure/route, endpoint and comparator in each original report, and directness to the selected MDD question", "role": "Supplementary; required to prevent extensions", "role_reason": "Needed to avoid combining mood in healthy people, nutritional-status associations and deficiency case reports into a placebo-controlled adjunctive effect in MDD.", "application_exception": "Do not delete indirect material, but do not invent numerical values for results that were not extracted.", "criterion": "Show separately the differences among healthy young women, observations in older Chinese adults and a deficiency case treated by parenteral→oral administration.", "basis": "M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M03 §3.2.4; custom boundaries on extensions", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Design questions about healthy people, correction of deficiency and observational associations separately, and distinguish them from the exact MDD adjunctive-treatment trial.", "current_reports": [ "S16", "S17", "S18" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S16 is a mood/cognition study in healthy young women who were not selected for depression. S17 concerns an observational association between thiamine status and depressive symptoms in older Chinese adults, not a controlled supplementation effect. S18 is a single parenteral→oral case of malnutrition and deficiency neuropathy due to depression; no result is borrowed as controlled antidepressant efficacy.", "condition_status": "Met", "status_reason": "Each material's exclusion/context role was linked to its original retained location. This is not a declaration that research is absent worldwide or that no direct effect exists.", "missingness": "The selected incremental effect of single-ingredient oral thiamine at 12 weeks in MDD is not verified in these materials.", "uncertainty": "The selected incremental effect of single-ingredient oral thiamine at 12 weeks in MDD is not verified in these materials.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Population, design, exposure/route, endpoint and comparator in each original report, and directness to the selected MDD question" }, { "item_id": "N32", "question_type": "Combinations, fatigue and other endpoints", "question": "Are S19–21 HDRS results for ordinary thiamine alone?", "needed": "Ingredients, populations, screening scales, endpoints/times and ingredient-specific direct comparisons in each original report", "role": "Supplementary; required to prevent extensions", "role_reason": "Needed to avoid attributing results for combinations, pregnancy or fatigue to the selected ingredient/total score.", "application_exception": "Do not decompose the contribution of B1+B2 or multiple micronutrients into B1 alone.", "criterion": "Explain the actual screening roles of combination/pregnancy studies, anxiety/stress/sleep and PBC fatigue.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M03 §3.2.1; detailed population conditions are custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M03 §3.2.4; custom boundaries on extensions", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "If the contribution of B1 alone is needed, design a separate direct comparison with the other ingredients/treatments matched.", "current_reports": [ "S19", "S20", "S21" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S19 studies a B1+B2 combination and anxiety, stress and sleep. S20 NUTRIMUM concerns pregnancy and multiple micronutrients; S21 concerns fatigue-focused material in primary biliary cholangitis. The retained record did not grade these as the selected MDD HDRS result or extract numerical values.", "condition_status": "Met", "status_reason": "Differences in ingredients, populations and endpoints were preserved, without pooling them as a direct single-ingredient B1 effect.", "missingness": "Direct results for the selected question and the individual contribution of B1 are unverified.", "uncertainty": "Direct results for the selected question and the individual contribution of B1 are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Ingredients, populations, screening scales, endpoints/times and ingredient-specific direct comparisons in each original report" }, { "item_id": "N33", "question_type": "Youth registration candidate", "question": "Were controlled adult results verified in NCT07793071?", "needed": "The official registration's identity, population, ingredient, route, design, time points, results, versions and actual acquisition events", "role": "Supplementary; required for interpreting registration", "role_reason": "Needed to avoid promoting an indexed title, app shell or API failure into actual adult results.", "application_exception": "Do not use details from a 3rd-party mirror as the original registration, or equate youth with an adult population.", "criterion": "Separate discovery of a candidate registration title from unverified original content/results.", "basis": "M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.1; detailed population conditions are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "After actually obtaining the registration content, compare population/design eligibility and separately track unpublished results as well.", "current_reports": [ "S15" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S15 preserves only the indexed title of NCT07793071 concerning depressive symptoms in youth. At that time, the official registration page was an app shell, the API failed and controlled adult results were not verified. Details from 3rd-party mirrors were not used as verified original data. Registration access was not attempted in this review.", "condition_status": "Unverified", "status_reason": "The existence of a candidate identifier/title is not verification of the original registration or adult results.", "missingness": "Original registration identity/content, population ages, results and current status are unverified.", "uncertainty": "Original registration identity/content, population ages, results and current status are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The official registration's identity, population, ingredient, route, design, time points, results, versions and actual acquisition events" }, { "item_id": "N34", "question_type": "Harm statements in the candidate trial", "question": "Does S01's statement of no adverse effects mean 0 events per arm?", "needed": "S01 event/person counts by arm, exposure/follow-up n, duration, AE definitions/collection and reasons for discontinuation", "role": "Supplementary; required for safety statements", "role_reason": "Needed to avoid turning the abstract's absence statement into complete ascertainment or an incidence of 0.", "application_exception": "Do not arbitrarily use the total of 51 participants or 12 weeks as an exact exposure denominator or ascertainment scope.", "criterion": "Separate the original wording from unverified event/person counts, exposure n, discontinuations and ascertainment.", "basis": "M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future trials should report systematic harm ascertainment and arm-level people/events, exposure and discontinuations separately from efficacy.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The S01 abstract states that there were no adverse effects in either group. Arm-level event/exposure counts, serious events, AE discontinuations and ascertainment methods are null or unverified. Do not turn this sentence into 0 events per arm or an incidence of 0.", "condition_status": "Unverified", "status_reason": "The reported wording is preserved, but there are no data to verify frequency or complete ascertainment.", "missingness": "Exact events/people by arm, exposure denominators, ascertainment and discontinuations are unverified.", "uncertainty": "Exact events/people by arm, exposure denominators, ascertainment and discontinuations are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S01 event/person counts by arm, exposure/follow-up n, duration, AE definitions/collection and reasons for discontinuation" }, { "item_id": "N35", "question_type": "Psychiatric events and long-term harms", "question": "Were suicide-related events, manic switch, worsening and long-term safety assessed?", "needed": "Psychiatric-event definitions, systematic ascertainment, arm-level n/duration, worsening/mania/suicide and long-term follow-up data", "role": "Supplementary; required for those safety extensions", "role_reason": "Needed to avoid extending a general AE statement in a short-term abstract to psychiatric events or overall safety.", "application_exception": "Do not turn unverified suicide/mania/worsening into absence of events or a causal finding of worsening.", "criterion": "Check the scope of separate psychiatric ascertainment, exposure time and long-term/special-population information.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M19 §19.2 design-specific harm questions; details of temporal relationships are custom-designed; M19 §19.1.2–19.2.4; custom application; Chamgap's own interpretive boundaries. Informed by M19 principles, not an official causality-tool implementation", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Collect psychiatric events using separate prespecified definitions and appropriate follow-up/surveillance, and separate them from efficacy total scores.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "Suicide-related events, mania/hypomania and psychiatric worsening in S01 are unverified (null). Separate assessment, temporal relationships after exposure, discontinuation/re-exposure and long-term harms are unverified. Do not extend the candidate result at 12 weeks to long-term safety, rare events or safety in all populations, including pregnancy/lactation.", "condition_status": "Unverified", "status_reason": "Symptom total scores and a general AE abstract alone cannot establish ascertainment, frequency or causality for separate events.", "missingness": "Direct data on psychiatric events, long-term/special populations and timing/discontinuation are unverified.", "uncertainty": "Direct data on psychiatric events, long-term/special populations and timing/discontinuation are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Psychiatric-event definitions, systematic ascertainment, arm-level n/duration, worsening/mania/suicide and long-term follow-up data" }, { "item_id": "N36", "question_type": "Harms in other candidates", "question": "How are the nausea/adverse-effect statements in S03 and S04 attributed?", "needed": "S03/S04 original events/people by arm, ascertainment, exposure/duration, discontinuations, products and CONSORT data", "role": "Supplementary; required for safety interpretation of other materials", "role_reason": "Needed to avoid adding events from other studies to harms in S01 or counting them as replications for the same product.", "application_exception": "Do not create event counts, exposure denominators or 0 events from descriptions of nausea or no important AEs.", "criterion": "Distinguish populations, products and durations from the corresponding reports' harm statements and denominator gaps.", "basis": "M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M04 §4.6.1–4.6.2; adaptation for harm data is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Safety syntheses should compare identities, populations, products and ascertainment, then separate unique events from frequencies.", "current_reports": [ "S03", "S04" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S03 preserves abstract statements of nonsevere nausea and no serious adverse effects, but arm-level events/exposure n are unverified. S04 records a statement of no important adverse effects in the B1 arm and an exclusion criterion for B1 allergy. Arm-level events/exposure and independent re-extraction of CONSORT discontinuation reasons are unverified.", "condition_status": "Partly verified", "status_reason": "The statements are attributed, but safety frequencies in other populations/products cannot be directly transferred to the candidate.", "missingness": "Harm denominators/ascertainment, events, discontinuations and product correspondence by arm are unverified.", "uncertainty": "Harm denominators/ascertainment, events, discontinuations and product correspondence by arm are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S03/S04 original events/people by arm, ascertainment, exposure/duration, discontinuations, products and CONSORT data" }, { "item_id": "N37", "question_type": "Separate oral-product SmPC", "question": "Does the Flamingo product information establish the candidate product and its harms?", "needed": "Documentation linking the candidate trial product to this product, and the actual SmPC/version and original harm data for the oral product", "role": "Supplementary; required for interpreting product safety", "role_reason": "Needed to avoid assigning a separate hydrochloride product's identity to the candidate trial's actual product/route.", "application_exception": "Do not transfer the frequency of hypersensitivity reported mainly with parenteral use into incidence in an oral trial.", "criterion": "Separate the 100 mg oral product, historical version and unknown gastrointestinal/hypersensitivity frequencies from the unverified candidate product.", "basis": "M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M19 §19.2.2–19.2.4, M03 §3.2.3; custom application; M19 §19.1.2–19.2.4; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Product-specific harm reviews should directly compare matched routes, products, exposed populations and event-occurrence/reporting systems.", "current_reports": [ "S06" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "S06 is the SmPC for Flamingo's oral Thiamine Hydrochloride 100 mg Tablets. The frequencies of gastrointestinal adverse effects and hypersensitivity reactions are unknown, and hypersensitivity reports are retained as predominantly parenteral. The emc update of 2025-09-08 and text revision date of 2025-02-18 are historical version information, not identification of either MDD trial product.", "condition_status": "Partly verified", "status_reason": "The separate product's general harm context was linked, but the candidate product and incidence cannot be established.", "missingness": "Correspondence with the actual candidate product, frequency in the oral trial and the current SmPC version are unverified.", "uncertainty": "Correspondence with the actual candidate product, frequency in the oral trial and the current SmPC version are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Documentation linking the candidate trial product to this product, and the actual SmPC/version and original harm data for the oral product" }, { "item_id": "N38", "question_type": "Nutritional upper limit and general context", "question": "What do an unset UL and general nutritional/medication context mean?", "needed": "Original official nutrition/excess-intake, vulnerable-population and interaction documents, and direct harm data matching the population and exposure", "role": "Supplementary; required for general safety extensions", "role_reason": "Needed to avoid using the absence of a UL or deficiency context as evidence of unlimited safety or MDD efficacy.", "application_exception": "Do not derive personal recommendations or MDD treatment effects from general information about intake/medication relationships.", "criterion": "Link the unset UL and excessive-intake warning in S05 to its role as context rather than efficacy evidence.", "basis": "M19 §19.1.2–19.2.4; custom application; Chamgap's own interpretive boundaries. Informed by M19 principles, not an official causality-tool implementation; M03 §3.2.1; detailed population conditions are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Assess concomitant-medication/excess-intake risks in the selected MDD population using separate actual exposure data.", "current_reports": [ "S05" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The S05 ODS summary records that no UL has been established, but the FNB cautions that excessive intake may cause adverse effects. The existence of sections on deficiency, at-risk groups and medication interactions provides general context, not a source of depression efficacy evidence. An unset UL does not mean unlimited safety.", "condition_status": "Met", "status_reason": "The safety/efficacy interpretation boundaries of the general material were checked. This does not mean that a specific concomitant-treatment risk in MDD or an individual dose has been verified.", "missingness": "Direct interactions and long-term/excess-intake safety for the selected population/actual product are unverified.", "uncertainty": "Direct interactions and long-term/excess-intake safety for the selected population/actual product are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original official nutrition/excess-intake, vulnerable-population and interaction documents, and direct harm data matching the population and exposure" }, { "item_id": "N39", "question_type": "Extensions to persistence, dose and remission", "question": "Does the total score at 12 weeks also answer questions about optimal dose, maintenance, response/remission and prevention?", "needed": "Direct dose comparisons, follow-up after discontinuation, prespecified subgroups/interactions and response/remission/relapse/suicide-event data", "role": "Supplementary; required for those extension claims", "role_reason": "Needed to avoid extending a narrow symptom comparison to dose selection, persistence or clinical events.", "application_exception": "Do not require every extension trial as a mandatory condition for constructing this table's direct 12-week question.", "criterion": "Clearly distinguish the selected total score from unverified extension questions.", "basis": "M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed; M03 §3.2.4; custom boundaries on extensions; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Address each extension question in a separate study with a prespecified direct comparison, definition, time point and denominator.", "current_reports": [ "S01", "S07" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The current candidate material does not establish optimal dose, long-term maintenance, persistence after discontinuation, effects in a deficient subgroup or augmentation of a stable SSRI. Response/remission, relapse and suicide prevention are also not the total-score outcome at 12 weeks in this table. Direct estimates for these extensions are unverified within the retained scope.", "condition_status": "Unverified", "status_reason": "Direct material needed for the extensions is unavailable, but this is not treated as failure of a mandatory event trial for the narrow total-score question.", "missingness": "Direct comparisons/durations, definitions and subgroup interactions for each extension are unverified.", "uncertainty": "Direct comparisons/durations, definitions and subgroup interactions for each extension are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Direct dose comparisons, follow-up after discontinuation, prespecified subgroups/interactions and response/remission/relapse/suicide-event data" }, { "item_id": "N40", "question_type": "Additional material and new research", "question": "Were original materials needed to fill current gaps distinguished from methods for future trials?", "needed": "S01 original Methods/product, HDRS version, arm-level tables/CI at 12 weeks, flow, registration/SAP, safety and corrections", "role": "Required", "role_reason": "Needed to avoid presenting acquisition of a full text and conduct of new research as the same action.", "application_exception": "Do not adopt a new minimum sample size, number of trials, dose or MCID without justification.", "criterion": "Distinguish obtaining current original reports/plans from proposals for eligible direct comparisons and analysis/reporting.", "basis": "M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M08 §8.1–8.2.3; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "In a direct randomized placebo comparison that clearly defines the product/route, MDD criteria and SSRI initiation, prespecify HDRS at 12 weeks, arm-level n/missing data, CI, an important difference and harms, and disclose all results.", "current_reports": [ "S01" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The first need is to obtain S01 original Methods, product/route, scale version, arm-level numerical values/CI at 12 weeks, analysis/flow, registration and harm data. Separately, methods are proposed for future research directly comparing single-ingredient oral ordinary thiamine in the same MDD/SSRI-initiation setting. No fixed sample size, dose, duration extension or efficacy grade is created.", "condition_status": "Met", "status_reason": "The additional materials in each row are gaps in the record, while future research is distinguished as a methodological proposal that has not yet been carried out.", "missingness": "Neither material acquisition nor a new trial has been performed; the original eligibility/effect gaps remain.", "uncertainty": "Neither material acquisition nor a new trial has been performed; the original eligibility/effect gaps remain.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S01 original Methods/product, HDRS version, arm-level tables/CI at 12 weeks, flow, registration/SAP, safety and corrections" }, { "item_id": "N41", "question_type": "Reference dates, original verdict and exception", "question": "Were the existing ?/null and calculator exception kept from being inherited as the new table's status?", "needed": "Original calculation inputs/errors, current-value exception, verification records and authoritative records of new evidence/condition-change events", "role": "Required", "role_reason": "Needed to avoid turning an uncalculated value into no effect, no human research or a score of 0 points.", "application_exception": "Do not adopt the historical calculator's validation error/pre-validation B as a new valid grade, or rerun the calculator.", "criterion": "Preserve the original cutoff and review dates, original grade/score, axes, exception and historical self-review.", "basis": "M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "If eligibility or the representation of rules is updated, separate the event, conditions and adjudication procedure, and preserve the entire previous original text.", "current_reports": [], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The original evidence cutoff is 2026-09-16, and this summary's review date is 2026-10-05. Preserve the original grade ?, uncalculated score (null), claim type B, six unscored downstream axes (null) and the no-human-study flag false. Preserve the original explanation that the calculator returned validation errors and a pre-validation B at that time, but B was not adopted. Original document quality A and single-assistant self-review are not independent clinical certification.", "condition_status": "Met", "status_reason": "Original values and the historical record of the exception were preserved, without newly inheriting statuses/scores, calculating or reassessing.", "missingness": "The stage 0 native-calculator representation and original eligibility/effect at 12 weeks remain unverified.", "uncertainty": "The stage 0 native-calculator representation and original eligibility/effect at 12 weeks remain unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original calculation inputs/errors, current-value exception, verification records and authoritative records of new evidence/condition-change events" }, { "item_id": "N42", "question_type": "Repeated visits and statistical model", "question": "How were analyses across multiple visits/scales and the adjusted model prespecified?", "needed": "Original protocol/SAP, analysis model, covariates, repeated-visit/multiplicity handling, effect of interest at 12 weeks and reasons for changes", "role": "Required", "role_reason": "Needed to avoid mixing comparisons at 3, 6 and 12 weeks and selection of favorable analyses into the same 12-week estimate.", "application_exception": "Without the original SAP, do not infer repeated-measures methods, multiplicity adjustments or covariate models.", "criterion": "Explain the actual adjusted/unadjusted effect of interest, handling of multiple time points/endpoints and unverified plans.", "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed", "condition_origin": "Designed for a known development case after actually reading the current stored materials individually. This was not blinded, clinically preregistered, or an official tool implementation/certification.", "proposed_research": "Future direct comparisons should prespecify the effect of interest at 12 weeks, primary endpoint, visit-specific comparisons, covariates, multiplicity handling and sensitivity to missing data.", "current_reports": [ "S01", "S02" ], "existence": "The corresponding Korean/structured content, report bibliography/extractions and historical records are preserved in the current stored summary. This is not an exhaustive external check of existence.", "acquired_read": "Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review.", "observation": "The adjusted/unadjusted effect of interest and multiplicity-handling method in S01 are unverified. Visits at 0, 3, 6 and 12 weeks are preserved, but the repeated-measures model, covariates, primary/secondary endpoints and plans for multiple comparisons across time points were not verified. Do not reconstruct a statistical model from the difference between nonsignificance at 12 weeks and a favorable result at 6 weeks.", "condition_status": "Unverified", "status_reason": "Without material comparing the analysis plan and actual model, how the selected estimate was handled cannot be established.", "missingness": "The SAP, adjusted model, covariates, adjustments for multiple visits/endpoints and reasons for changes are unverified.", "uncertainty": "The SAP, adjusted model, covariates, adjustments for multiple visits/endpoints and reasons for changes are unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original protocol/SAP, analysis model, covariates, repeated-visit/multiplicity handling, effect of interest at 12 weeks and reasons for changes" } ], "reports": [ { "report_id": "S01", "title": "Ghaleiha et al. Adjuvant thiamine improved standard treatment in patients with major depressive disorder (2016)", "url": "https://link.springer.com/article/10.1007/s00406-016-0685-6", "report_type": "Candidate original report and partial publisher record", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "Reports 51 participants (MDD inpatients), HDRS >24 and thiamine versus placebo at initiation of a new SSRI. The signal at 6 weeks is favorable, but the between-group mean difference at 12 weeks is nonsignificant, and the exact effect, CI, P value and n by arm are unverified. Statements of within-group improvement and no adverse effects are not, respectively, an incremental causal effect and an incidence of 0.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Paper abstract and partial publisher web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S01-M1", "url": "https://link.springer.com/article/10.1007/s00406-016-0685-6", "parent_url": "https://link.springer.com/article/10.1007/s00406-016-0685-6" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S01-M2", "url": null, "parent_url": "https://link.springer.com/article/10.1007/s00406-016-0685-6" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1007/s00406-016-0685-6" } ] }, { "report_id": "S02", "title": "Ghaleiha 2016 original Figure 1", "url": "https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif", "report_type": "Historical record of visual inspection of the original S01 figure", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "A record of qualitative inspection at that time of HDRS trajectories at baseline and 3, 6 and 12 weeks. The favorable-at-6-weeks/nonsignificant-at-12-weeks statements are preserved, but the figure was not digitized and means, SD/SE or CIs were not reconstructed. The S/S/L/M labels are not a verified MCID.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original figure", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S02-M1", "url": "https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif", "parent_url": "https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif" } ], "links": [ { "label": "Source", "url": "https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif" } ] }, { "report_id": "S03", "title": "Wattanathamrak. The Effectiveness of Adjunctive Thiamine (vitamin B1) with Standard Treatment in Patients with Major Depressive Disorder", "url": "https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535", "report_type": "Abstract/bibliographic record of a separate original controlled MDD study", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-WATTANATHAMRAK-2019", "independent_replication": null, "observed_result": "In 50 participants with MDD receiving inpatient/outpatient care, aged 18–60 years, 300 mg/day is added to standard treatment. The HRSD improvement P-value sequence .004/.031/.035 is preserved, but attribution to visits/estimands and the effect at 12 weeks, CI and n by arm are unverified. Allocation by drawing lots, the nausea statement and the publication-date/issue conflict are retained separately.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Paper abstract and journal bibliographic web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S03-M1", "url": "https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535", "parent_url": "https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S03-M2", "url": null, "parent_url": "https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535" } ], "links": [ { "label": "Source", "url": "https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535" } ] }, { "report_id": "S04", "title": "Moti et al. The Effects of Thiamine Supplementation on General Health and Infertility Treatment Outcomes in Women with PCOS (2024)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/", "report_type": "Historical record of extraction from the HTML full text of the PCOS/IVF original report", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-MOTI-2024", "independent_replication": null, "observed_result": "A PCOS/IVF study with 35/35 participants randomized and 32/32 participants analyzed, using oral treatment for 4 weeks at 300 mg/day. GHQ depression means (SDs) are 16.46(4.98)/15.84(5.53) at baseline and, at 4 weeks, 10.96(4.93)/16.25(4.87), with reported between-group P<.001. Eligibility, scale and time point differ, and an MDD subgroup effect is unverified. Notes on the original threshold/printed percentages and outcome hierarchy, and failure to obtain the original registration, are preserved.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S04-M1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/", "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/" }, { "material_type": "Original protocol, analysis-plan and registration documents", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S04-M2", "url": null, "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/" } ] }, { "report_id": "S05", "title": "NIH Office of Dietary Supplements: Thiamin, Health Professional Fact Sheet", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/", "report_type": "Official nutrition/general harm context", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Preserve the unset UL and the FNB's caution about harm from excessive intake. These do not establish unlimited safety, a personal dose for the selected MDD product or efficacy. No specific medication interactions were newly extracted in this review.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full official web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S05-M1", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/", "parent_url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ], "links": [ { "label": "Source", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ] }, { "report_id": "S06", "title": "Thiamine Hydrochloride 100 mg Tablets, Flamingo Pharma (UK), SmPC", "url": "https://www.medicines.org.uk/emc/product/13528/smpc", "report_type": "SmPC for a separate oral hydrochloride product", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Preserve the unknown frequency of gastrointestinal/hypersensitivity reactions and the route limitation that hypersensitivity reports are predominantly parenteral. The emc update of 2025-09-08 and text revision of 2025-02-18 are records from that time, not verification of the original MDD product or oral incidence.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full official product web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S06-M1", "url": "https://www.medicines.org.uk/emc/product/13528/smpc", "parent_url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ], "links": [ { "label": "Source", "url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ] }, { "report_id": "S07", "title": "Sousa Santos and Braga Reis: Eficacia de la suplementación con tiamina para mejorar los síntomas depresivos. Revisión basada en la evidencia (2023)", "url": "https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048", "report_type": "Historical record of selected PDF portions of a secondary (2nd) review", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "The review records oral 300 mg/day, fluoxetine 20 mg/day and unspecified formulation. Do not promote these to route, dose or product values verified in the S01 original. Preserve the limitations of access to selected portions and the distinction between response/remission P values and severity P values.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text review paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S07-M1", "url": "https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048", "parent_url": "https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048" } ], "links": [ { "label": "Source", "url": "https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048" } ] }, { "report_id": "S08", "title": "Dhir et al. Neurological, Psychiatric, and Biochemical Aspects of Thiamine Deficiency in Children and Adults (2019)", "url": "https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full", "report_type": "Record of an indexed excerpt from a secondary (2nd) mechanistic/deficiency review", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "The review calls the S01 population deficient, but neither deficiency nor repletion was verified in the accessed original. Without original baseline tests and thresholds, the MDD population is not established as deficient or replete.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text review paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S08-M1", "url": "https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full", "parent_url": "https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full" } ], "links": [ { "label": "Source", "url": "https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full" } ] }, { "report_id": "S09", "title": "AIHTA Project Report 182, Combination Therapy with Antidepressants and Vitamin B (2026)", "url": "https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf", "report_type": "Record of selected searches/bibliographic mapping in an HTA report", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "A historical record stating that the entire 97-page report was not read. Bibliographic mapping at that time used only term searches and PDF page 68 (reference 86), without borrowing decisive efficacy facts.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full assessment report", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S09-M1", "url": "https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf", "parent_url": "https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf" } ], "links": [ { "label": "Source", "url": "https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf" } ] }, { "report_id": "S10", "title": "PubMed record 26984349", "url": "https://pubmed.ncbi.nlm.nih.gov/26984349/", "report_type": "Official PubMed index/abstract record", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "A record of PMID 26984349, the same DOI and the indexed abstract. Preserve the original limitation that direct opening returned an empty result and this was not a completed search of the native PubMed database.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full official index web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S10-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/26984349/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/26984349/" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S10-M2", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/26984349/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/26984349/" } ] }, { "report_id": "S11", "title": "Basel repository record for Ghaleiha 2016", "url": "https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d", "report_type": "Abstract/metadata record in the Basel institutional repository", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "A historical record that no exposed full-text file was obtained. Do not substitute the repository's default displayed date for the publisher's publication date or add separate participants/effects.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full institutional bibliographic web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S11-M1", "url": "https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d", "parent_url": "https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S11-M2", "url": null, "parent_url": "https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d" } ], "links": [ { "label": "Source", "url": "https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d" } ] }, { "report_id": "S12", "title": "Fribourg repository record for Ghaleiha 2016", "url": "https://folia.unifr.ch/global/documents/299267", "report_type": "Abstract/metadata record in the Fribourg institutional repository", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "Access is recorded as abstract/citation metadata, and notes and the extracted statement are empty strings. Do not fill these blanks with independent results, full-text acquisition or reported absence of an effect.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full institutional bibliographic web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S12-M1", "url": "https://folia.unifr.ch/global/documents/299267", "parent_url": "https://folia.unifr.ch/global/documents/299267" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S12-M2", "url": null, "parent_url": "https://folia.unifr.ch/global/documents/299267" } ], "links": [ { "label": "Source", "url": "https://folia.unifr.ch/global/documents/299267" } ] }, { "report_id": "S13", "title": "ResearchGate record and publisher preview, Ghaleiha 2016", "url": "https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial", "report_type": "ResearchGate aggregation and single-page original-report preview record", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "A historical record of access only to the single-page preview at p.695 and the abstract; preview download failed. Citing-article content on the same page is not treated as the Ghaleiha original. This was not reading the entire full text.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S13-M1", "url": "https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial", "parent_url": "https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S13-M2", "url": null, "parent_url": "https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial" } ], "links": [ { "label": "Source", "url": "https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial" } ] }, { "report_id": "S14", "title": "SciSpace record, Ghaleiha 2016", "url": "https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2", "report_type": "SciSpace aggregated metadata/abstract record", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": "TF-GHALEIHA-2016", "independent_replication": null, "observed_result": "A record stating that the full PDF was not acquired and AI-generated summaries were not used. Displayed abstract/bibliographic information is not independent replication or verification of the original full text.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S14-M1", "url": "https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2", "parent_url": "https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S14-M2", "url": null, "parent_url": "https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2" } ], "links": [ { "label": "Source", "url": "https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2" } ] }, { "report_id": "S15", "title": "ClinicalTrials.gov NCT07793071: Evaluating Thiamine (Vitamin B1) as Adjunctive Therapy for Youth With Depressive Symptoms", "url": "https://clinicaltrials.gov/study/NCT07793071", "report_type": "Indexed-title record of the ClinicalTrials.gov youth candidate", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Only the youth depressive symptoms title for NCT07793071 was preserved. The original page is recorded as an app shell/API failure, and controlled adult results were not verified. Current status, design and age details were not checked in this review.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full official registration web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S15-M1", "url": "https://clinicaltrials.gov/study/NCT07793071", "parent_url": "https://clinicaltrials.gov/study/NCT07793071" }, { "material_type": "Original protocol, analysis-plan and results documents", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S15-M2", "url": null, "parent_url": "https://clinicaltrials.gov/study/NCT07793071" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT07793071" } ] }, { "report_id": "S16", "title": "Benton et al. thiamine supplementation and mood/cognition in young women", "url": "https://europepmc.org/article/med/9122365", "report_type": "Indexed abstract of the original study in healthy young women", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Recorded as a mood/cognition study in healthy young women, not an objectively depression-selected population. PMID 9122365 is preserved, and a DOI was not adopted. No numerical efficacy results for the selected MDD question were extracted.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full index web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S16-M1", "url": "https://europepmc.org/article/med/9122365", "parent_url": "https://europepmc.org/article/med/9122365" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S16-M2", "url": null, "parent_url": "https://europepmc.org/article/med/9122365" } ], "links": [ { "label": "Source", "url": "https://europepmc.org/article/med/9122365" } ] }, { "report_id": "S17", "title": "Zhang et al. Thiamine nutritional status and depressive symptoms are inversely associated among older Chinese adults", "url": "https://pubmed.ncbi.nlm.nih.gov/23173173/", "report_type": "Index/reference record of an original observational study in older Chinese adults", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Design screening of an observational study on an inverse association between thiamine nutritional status and depressive symptoms. Original numerical results were not extracted and are not transferred to adjunctive efficacy with an SSRI in MDD.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full official index web document", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S17-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/23173173/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/23173173/" }, { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S17-M2", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/23173173/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/23173173/" } ] }, { "report_id": "S18", "title": "Melki et al. Thiamine Deficiency Neuropathy in a Patient with Malnutrition due to Melancholic Depression (2024)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/", "report_type": "Indexed excerpt of a malnutrition/deficiency-neuropathy case report", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "A case of deficiency neuropathy with malnutrition due to melancholic depression. A single case treated first parenterally and then orally is not controlled antidepressant efficacy evidence for ordinary oral single-ingredient B1, and no results were borrowed.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S18-M1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/", "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/" } ] }, { "report_id": "S19", "title": "Tao et al. Impact of Vitamin B1 and Vitamin B2 Supplementation on Anxiety, Stress, and Sleep Quality (2025)", "url": "https://www.mdpi.com/2072-6643/17/11/1821", "report_type": "Indexed excerpt of an original B1+B2 combination study", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "A study of anxiety, stress and sleep with a B1+B2 combination, differing from the fixed depression-scale/single-ingredient B1 question. No original efficacy grading or decomposition of the B1 contribution was performed.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S19-M1", "url": "https://www.mdpi.com/2072-6643/17/11/1821", "parent_url": "https://www.mdpi.com/2072-6643/17/11/1821" } ], "links": [ { "label": "Source", "url": "https://www.mdpi.com/2072-6643/17/11/1821" } ] }, { "report_id": "S20", "title": "NUTRIMUM micronutrient trial (2024)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/", "report_type": "Indexed excerpt of the original NUTRIMUM study", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "Pregnancy and a multiple-micronutrient formulation differ from ordinary thiamine alone. For this question, only the screening record of exclusion without efficacy extraction is preserved.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S20-M1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/", "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/" } ] }, { "report_id": "S21", "title": "Bager et al. high-dose thiamine in primary biliary cholangitis (2024)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/", "report_type": "Indexed excerpt of an original high-dose thiamine study in PBC", "existence": "Identity/extraction and access records exist in the currently retained sources/citations. This is not new verification of current external public availability/publication status.", "acquired_read": "Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review.", "study_family": null, "independent_replication": null, "observed_result": "A disease population focused on fatigue in primary biliary cholangitis. This is not an HDRS efficacy result in a depression-selected population, and the previously completed record was not researched anew or regraded.", "result_level": "Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full-text paper", "public_status": "Currently unverified (no external lookup)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access.", "material_id": "S21-M1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/", "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review." } ], "status_dictionary": { "Met": "The record's identity, boundaries and conditions for preservation/distinction can be explained. This differs from confirmation of treatment efficacy/safety or official certification.", "Partly verified": "Some information for the selected condition is linked, but specific gaps remain.", "Unverified": "Required values/conditions cannot be established within the material currently read. This does not mean no research, an effect of 0 or 0 events.", "Conflicting information": "A specific discrepancy in the level of verification of deficiency statements or in original bibliographic details/reporting/hierarchy. Differences in time points, denominators or designs alone are not automatically designated as conflicts.", "Not applicable": "Used only when there is an actual reason why the selected condition does not apply.", "Not reported": "Limited to a gap at a specific retained location actually read; not extended to nonreporting throughout the external original paper.", "Inaccessible": "Used only when an actual current access attempt has failed. This differs from external access not attempted in this review or historical failures.", "Review incomplete": "An actual pending state of individual table preparation/review, separate from unverified/unread clinical material." }, "study_overlap": { "state": "These are retained family links for comparison candidates and indirect materials. TF-GHALEIHA-2016 (S01, S02, S10, S11, S12, S13, S14): strongest candidate anchor; no fully verified directly eligible family selected · unresolved_directness; not eligible for grading yet / TF-WATTANATHAMRAK-2019 (S03): additional controlled MDD signal; no pooling or replication grade · unresolved_route_form_scale_version_background_and_time / TF-MOTI-2024 (S04): controlled adjacent evidence, excluded from the locked MDD HDRS comparison · indirect_population_and_endpoint Same DOI/repositories/figure are one cohort. Do not sum S01/S02/S10–S14 participants. No meta-analysis. The comparison-candidate family count and grading-eligible count in the record from that time are not the total number of unique trials. The confirmed number of independent efficacy studies and the total participant count are unverified. Multiple reports from the same family are not added as independent replications.", "unique_trial_count": null, "unique_participant_count": null, "reason": "These are retained family links for comparison candidates and indirect materials. TF-GHALEIHA-2016 (S01, S02, S10, S11, S12, S13, S14): strongest candidate anchor; no fully verified directly eligible family selected · unresolved_directness; not eligible for grading yet / TF-WATTANATHAMRAK-2019 (S03): additional controlled MDD signal; no pooling or replication grade · unresolved_route_form_scale_version_background_and_time / TF-MOTI-2024 (S04): controlled adjacent evidence, excluded from the locked MDD HDRS comparison · indirect_population_and_endpoint Same DOI/repositories/figure are one cohort. Do not sum S01/S02/S10–S14 participants. No meta-analysis. The comparison-candidate family count and grading-eligible count in the record from that time are not the total number of unique trials. The confirmed number of independent efficacy studies and the total participant count are unverified. Multiple reports from the same family are not added as independent replications." }, "history": [ { "date": "2026-11-06", "kind": "Separation of public-facing display and data", "view_version": "1.0", "change": "Public-facing display and data were prepared from the existing 42 items. No new clinical search, change in verification status or grading was performed." } ], "language": "en", "translation_date": "2026-11-06" }