CHAMGAP

Antidepressant maintenance × complete relapse prevention — evidence sheet distinguishing remaining 52-week events

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyHave the complete-prevention claim, subclaim grade D and parent relapse-reduction grade B been kept separate?Required
The selected existing claim is ‘Maintenance completely prevents relapse’, with original grade D and a note that 39% relapsed despite maintenance. The parent concerns average relapse reduction, B with 70 points and Caution.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score, status and axes are not filled with parent values. This is not a new grade assessment.
Separate preservation of the subclaim wording, grade and note and the parent verdict
Proposal: Link additional materials while distinguishing complete prevention from average relapse reduction.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyWhat were the original population's remission, long-term use and consideration of discontinuation conditions?Required
Participants were adults who felt well enough to consider discontinuation, had at least two previous depressive episodes or at least two years of treatment, and were long-term users. The trial included 150 UK general practices.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The findings are not automatically applied to other diseases, treatment durations, remission states or populations. Detailed baseline and eligibility tables remain unread.
Age, remission, previous episodes, treatment history, eligibility and denominators
Proposal: Obtain original eligibility, baseline characteristics, remission assessment and relapse history.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyHave the four antidepressants' specific study conditions been extended to all medications?Required
ANTLER included users of specified doses of citalopram, fluoxetine, sertraline and mirtazapine. Original doses are preserved in the complete existing review summary.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not extend the finding to complete prevention with other medications, doses or patient groups or create instructions for taking, maintaining or discontinuing medication. Original medication-specific denominators and effects remain unread.
Recording included medications, original study doses, exposure and group composition
Proposal: Obtain medication-specific inclusion, baseline exposure, denominators and prespecified subgroup materials.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyWhat was the actual comparison between maintenance and tapering to matching placebo?Required
The randomized comparison was long-term maintenance versus tapering and switching to matching placebo. The original study's 1~2-month taper is preserved only as a historical condition.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not equated with abrupt discontinuation or every discontinuation method. No new taper schedule, medication instructions or treatment substitution is created.
Historical interventions, placebo switching, common treatments and actual exposure
Proposal: Obtain original intervention, placebo, actual exposure, common-treatment and change materials.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyAre the 478 randomized participants and group-specific absolute relapse denominators preserved?Required
The 478 participants were allocated to maintenance, 238, or tapering to placebo, 240. Absolute relapse counts were 92/238 versus 135/240.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Two reports of the same trial, multiple medications and other subclaims are not added as new participants.
Randomization, analysis, group-specific absolute events and follow-up denominators
Proposal: Obtain original participant flow, allocation, absolute event tables and missing-data mapping by group.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyDoes the complete-prevention claim agree with the actual maintenance-group events?Required
The existing review summary and note record relapse within 52 weeks in 92/238 (39%) of the maintenance group. The preserved summary explicitly states that maintenance did not eliminate relapse.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Average reduction is not converted into complete prevention for every person or duration. No new individual prediction or guarantee is made.
Direct evidence for the selected duration, group, relapse definition and event counts
Proposal: Link original relapse definitions, ascertainment, events by duration and scope of individual applicability.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyWhat were the relapse symptom instrument, assessment and ascertainment times?Required
The preserved summary records relapse assessed with a depression symptom instrument as a patient-important treatment target and analyzes time to first relapse over 52 weeks.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invent an instrument name, exact diagnostic criteria, measurement schedule or assessor details absent from the original material.
Instrument, episode definition, ascertainment, measurement times and group denominators
Proposal: Obtain original relapse definitions, instrument, assessments, ascertainment times and tables.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyAre 39% versus 56% and the absolute 17%p difference preserved as originally recorded?Required
Preserve the original wording: maintenance 92/238 (39%) versus discontinuation 135/240 (56%), an absolute difference of 17%p.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new proportions, risk differences, RR, NNT, absolute-difference CI or event examples are calculated. Average reduction is not complete prevention.
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group
Proposal: Obtain original absolute-difference, CI, denominator and test materials.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyAre the discontinuation-versus-maintenance HR direction, CI and P preserved?Required
The discontinuation-versus-maintenance HR is 2.06 (95% CI 1.56~2.70), P<0.001.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invert this into a maintenance-versus-discontinuation HR or convert it into a relapse risk ratio or individual complete-protection rate. Detailed model and adjustment variables remain unread.
Time-to-event effect, comparison direction, CI, test and model
Proposal: Obtain the original effect of interest, HR direction, model, tests and denominators.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyAre the 468 participants in the primary time-to-event analysis the same denominator as the 478 for absolute relapse counts?Required
The 10 participants without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis but included in absolute relapse counts. The evidence list records 468 participants in the primary analysis.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not change the absolute-event denominator to 468 or newly certify the primary analysis as an all-participant ITT analysis. No new group-specific complete-case counts are calculated.
Mapping relapse timing, event occurrence, complete-case exclusions and denominators
Proposal: Obtain original analysis populations, missing timing, group denominators and event mapping.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyAre the best- and worst-case sensitivity analyses and gaps in effect magnitude retained?Required
The preserved summary records that sensitivity analyses using best- and worst-case assumptions remained in the same direction.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Consistent direction is not used to certify resolution of all missing-data bias, an exact effect or complete follow-up. Detailed numbers remain unread.
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals
Proposal: Obtain original sensitivity-analysis plans, assumptions, effects, intervals and denominators.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyAre adherence of 70% and 52% and restarting of 39% distinguished from relapse proportions?Required
Adherence was 70% in maintenance and 52% in discontinuation; 39% of the discontinuation group restarted a clinician-prescribed antidepressant before trial end.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not merge 39% restarting in discontinuation with 39% relapse in maintenance as the same event. No new adherer effects, reasons for restarting or denominators are calculated.
Actual exposure, adherence definitions, restarting, duration and event relationships
Proposal: Obtain original exposure, adherence, restarting, timing, event mapping and effects of interest.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyHas the magnitude of possible withdrawal-versus-relapse misclassification been established?Required
The preserved summary states that withdrawal symptoms were greater at 12 weeks in discontinuation and possible relapse misclassification could explain some findings, but its magnitude was not established.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not assert that withdrawal explains the entire difference or newly certify that there was no misclassification.
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses
Proposal: Obtain original withdrawal and relapse definitions, timing, assessment, sensitivity and distinction analyses.
14 Partly verified Full text not readStored summary read N14 · Comparative efficacyHave the original modified DESS means, difference, CI and direction been kept separate?Required
At 12 weeks, modified DESS was 3.1 in discontinuation versus 1.3 in maintenance, with the original between-group difference 1.9 (95% CI 1.5~2.3).
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not subtract the means again to revise the recorded difference or convert it into a new P, CI, denominator or relapse count. Adjustment and instrument definitions remain unread.
Withdrawal instrument, time point, group order, original difference, interval and denominators
Proposal: Obtain original DESS measurements, model, recorded difference, group denominators and repeated time points.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyHave matching-tablet blinding and limitations of actual allocation guesses been distinguished?Required
The existing review summary records a double-blind trial using matching tablets, but discontinuation participants guessed allocation better.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Nominal blinding alone does not certify complete actual blinding or resolution of all bias. Guessing proportions and allocation-concealment details remain unread.
Allocation, concealment, blinding, allocation guesses and analyst procedures
Proposal: Obtain original blinding, guessing, allocation, measurement and analysis procedures.
16 Partly verified Full text not readStored summary read N16 · Comparative efficacyAre the prespecified first-relapse endpoint, registration and analysis hierarchy actually linked?Required
The evidence-list endpoint is time to first relapse over 52 weeks, and the registration identifiers are ISRCTN15969819 · EudraCT2015-004210-26.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new registration or SAP reading or registration URL construction is performed. Complete prevention is not created as a separate prespecified endpoint of the original trial.
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans
Proposal: Obtain original registration, plans, analysis hierarchy and change history.
17 Unverified Full text not readStored summary read N17 · Comparative efficacyDo gaps in secondary outcomes, medication or baseline-history subgroups and individual prediction remain?Required
The preserved summary states that the trial did not identify who could discontinue safely.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not create universal protection with maintenance, individual safe discontinuation, medication rankings or baseline-history effects.
Prespecified subgroups, interactions, denominators, effects and prediction materials
Proposal: Obtain original subgroup, interaction, individual-prediction and secondary-outcome plans and denominators.
18 Partly verified Full text not readStored summary read N18 · Comparative efficacyIs the relationship to the other claim about 44% without relapse in discontinuation retained?Required
The existing review summary and sibling subclaim preserve the wording that 44% of the discontinuation group did not relapse within 52 weeks.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This value is not newly calculated or converted into advice that every person can or cannot discontinue safely.
Relationships among shared participants, relapse or non-relapse and other subclaims
Proposal: Link the two subclaims while retaining their relationship to the same trial, duration and denominators.
19 Partly verified Full text not readStored summary read N19 · Comparative efficacyHas the 52-week effect been kept from extending to permanent prevention or other clinical outcomes?Required
The selected original materials' central duration is 52 weeks, and maintenance participants also relapsed.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The 52-week reduction is not extended to lifelong absence of relapse, function, quality of life, survival or treatment benefit for every disease.
Direct outcomes including long-term follow-up, episodes, function and deaths
Proposal: Obtain direct relapse, clinical-function and long-term outcome materials separately by duration.
20 Partly verified Full text not readStored summary read N20 · Comparative efficacyDo Kato's 40 studies, 8,890 participants and original responses concern the same population as ANTLER?Required
Kato pooled 40 studies and 8,890 participants from varied post-acute-treatment maintenance-versus-placebo-switch trials.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not treated as the same direct comparison as the real discontinuation decision among long-term primary-care users. Populations, durations and overlap by included trial remain unread.
Review populations, post-acute maintenance, durations, denominators and trial mapping
Proposal: Obtain the review's original eligibility, included trials, durations, denominators and relationship to ANTLER.
21 Partly verified Full text not readStored summary read N21 · Comparative efficacyAre review results of 20.9% maintenance versus 39.7% placebo and the OR, CI and P preserved within their original scope?Required
The review reports maintenance 20.9% versus placebo switch 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Maintenance 20.9% also does not mean complete prevention. The original OR is not converted into ANTLER's HR or an individual protection rate. No new proportions or differences are calculated.
Pooled relapse effects, group proportions, OR, intervals, tests and denominators
Proposal: Obtain original pooled models, trial-specific effects, denominators, definitions and heterogeneity.
22 Partly verified Full text not readStored summary read N22 · Comparative efficacyHave NEJM, the detailed NIHR report and the review been kept from being added as new independent trials?Required
NEJM and NIHR HTA are two reports of the same ANTLER trial. The preserved summary states that the review supports the same direction but was not counted as an independent repeat of the ANTLER question.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Reports, medications, subclaims and the review's 40 studies are not added as new independent trials or participants. Final independent counts and total participant sums remain unrecorded.
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions
Proposal: Link additional reports through original identifiers and preserve relationships among shared populations and included trials.
23 Partly verified Full text not readStored summary read N23 · Comparative efficacyHave gaps in public funding, sponsorship, product supply, affiliations and external analysis been distinguished?Required
Preserve NIHR HTA 13/115/48, PRIMENT NIHR core support and UCL sponsorship. The preserved summary records that donated trial medication or placebo from a pharmaceutical company was not described in the NEJM or NIHR reports.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original non-reporting is not converted into certification of no donated supply. Detailed company affiliations and external-analysis roles remain unread.
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles
Proposal: Obtain original support, supply, affiliations, research roles and analysis disclosures separately.
24 Partly verified Full text not readStored summary read N24 · Comparative efficacyIs the original information level for review funding and involvement in included trials retained?Required
The existing review summary records Japanese Ministry of Health, Labour and Welfare grants H29-SEISHIN-ippan-001 and 19GC1012 for the review.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Review support is not extended to certification that all 40 included studies had public funding, independence or no product supply.
Review support, funding by original trial, authors and product or analysis roles
Proposal: Obtain original review and trial-specific support, affiliations, products and analysis relationships.
25 Partly verified Full text not readStored summary read N25 · Supplementary harm evidenceAre serious-adverse-event participant counts, proportions and denominators distinguished from relapse?Required
Original safety information records serious adverse events in 9 maintenance participants (4%) versus 8 discontinuation participants (3%).
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not convert these into event counts, medication-related harms or statistically significant safety differences. No new differences, P, CI or proportions are calculated. Denominator, collection and relatedness details remain unread.
SAE definitions, participants versus events, group denominators, relatedness and exposure tables
Proposal: Obtain original SAE definitions, group-specific events and participants, denominators, relatedness, exposure and discontinuation.
26 Partly verified Full text not readStored summary read N26 · Supplementary harm evidenceHave the original duration and scope of 0 deaths or suicide attempts been distinguished from long-term absence of risk?Required
Original safety information records 0 deaths and suicide attempts in both groups.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Zero events are not extended to absence of every rare harm, long-term safety or longevity benefit. No new risk CI or numerical examples are created.
Event definitions, collection, duration, exposure, denominators and rare-harm materials
Proposal: Obtain original event collection, exposure, denominators, duration and long-term rare-harm materials.
27 Partly verified Full text not readStored summary read N27 · Supplementary harm evidenceDo gaps remain in withdrawal symptoms, other maintenance-treatment harms and discontinuation applicability?Required
The preserved summary records increased withdrawal symptoms 12 weeks after discontinuation and possible misclassification of some relapse events. The parent safety status is Caution.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Withdrawal is not wholly equated with relapse or maintenance-medication harm. No long-term harm rates or maintenance or discontinuation instructions outside the original materials are created.
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up
Proposal: Obtain original withdrawal, maintenance-medication harm, exposure, discontinuation and long-term materials separately.
28 Unverified Full text not readStored summary read N28 · Supplementary harm evidenceHave repeated harms and applicability to other medications, populations and exposures been kept from new certification?Required
Current materials compare maintenance with tapering to placebo among particular long-term users in remission; the review concerns varied maintenance trials.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not advise an individual to maintain, discontinue, taper or restart medication or certify complete prevention or safety for all medications and populations.
Direct effects or harms and report relationships by population, medication and duration
Proposal: Link direct comparisons and harm materials for new populations, medications and exposures separately.
29 Partly verified Full text not readStored summary read N29 · Comparative efficacyAre the summary, three article URLs, registration records and original-material access distinguished?Required
The complete parent verdict summary was read for production, and three PubMed URLs, original DOIs and registration strings were linked.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new URLs are constructed from identifiers. External abstracts, full texts, registrations, protocols and SAP remain unread, with no separate link test.
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records
Proposal: Link original materials supplied by the user with individual types and actual access status.
30 Partly verified Full text not readStored summary read N30 · Comparative efficacyAre the cutoff date, languages, empty values, original verdict, candidate history and production status preserved?Supplementary
Preserve 2026-08-26, empty correction and deliberation values, Korean and English drafts, parent B70, Caution and axes, and subclaim grade D. Original review-pending and production-eligibility markers are historical records.
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim scores are not filled. Existing content review remains incomplete; review-pending activation and completion markers are false, new units are 0 and the final independent total is unrecorded.
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review
Proposal: Reflect additional materials and decisions through preservation of original wording and separate events.
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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Adults on long-term treatment who felt well enough to consider discontinuation; at least two previous episodes or at least two years of treatment; UK primary care
Ingredient, formulation and route
Historical study exposure to long-term maintenance of four specific antidepressants; not a recommendation to maintain treatment
Dose
Original included medications and doses are preserved in the complete summary; no individual medication, tapering, discontinuation or restarting instructions are created
Comparator
Tapering to matching placebo in the original trial; usual concomitant treatment and detailed actual exposure remain unread
Measured outcome
Selected complete-relapse-prevention claim; distinguish average reduction from the direct original finding of 92/238 (39%) maintenance participants relapsing by 52 weeks
Duration
Original duration 52 weeks; the original 1~2-month taper and 12-week withdrawal measurement are historical study conditions and measurement times, not instructions
Questions outside this scope
Repurposing average reduction as complete prevention for every person or duration; Mixing the 468-participant time-to-event denominator with the 478-participant absolute-event denominator; Merging withdrawal, relapse, restarting and SAE as the same events; Certifying all medications, populations, lifelong prevention or individual prediction; Recommendations to maintain, discontinue, taper or restart treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Lewis G, Marston L, Duffy L, et al. Maintenance or Discontinuation of Antidepressants in Primary Care. N Engl J Med. 2021;385:1257-1267. PMID: 34587384. DOI: 10.1056/NEJMoa2106356.

Publisher · PubMed

Material type
Reports of the same ANTLER trial
Materials actually read
Summary read; external materials not read
Findings recorded in the stored summary
Relapse 92/238 (39%) versus 135/240 (56%); discontinuation-versus-maintenance HR 2.06 (95% CI 1.56~2.70), P<0.001; absolute difference 17%p
Record level
Preserved summary; not the result of individually comparing the original texts of the two ANTLER reports
Study overlap and independent replication
NEJM and NIHR HTA reports of the same ANTLER trial share the same participants across three subclaims. The 40-study meta-analysis was not originally counted as an independent repeat of the ANTLER question; overlap among included trials and participants remains unread. Study-family identifiers link relationships and do not certify unique trial counts. Additional reports, medications, sibling questions, reviews and shared participants are not newly added as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryExisting link preservedSummary readSummary readStored parent-verdict summary
abstractExisting link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review

R02 · Duffy L, Clarke CS, Lewis G, et al. Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT. Health Technol Assess. 2021;25(69):1-62. PMID: 34842135. DOI: 10.3310/hta25690.

Publisher · PubMed

Material type
Reports of the same ANTLER trial
Materials actually read
Summary read; external materials not read
Findings recorded in the stored summary
Relapse 92/238 (39%) versus 135/240 (56%); discontinuation-versus-maintenance HR 2.06 (95% CI 1.56~2.70), P<0.001; absolute difference 17%p
Record level
Preserved summary; not the result of individually comparing the original texts of the two ANTLER reports
Study overlap and independent replication
NEJM and NIHR HTA reports of the same ANTLER trial share the same participants across three subclaims. The 40-study meta-analysis was not originally counted as an independent repeat of the ANTLER question; overlap among included trials and participants remains unread. Study-family identifiers link relationships and do not certify unique trial counts. Additional reports, medications, sibling questions, reviews and shared participants are not newly added as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryExisting link preservedSummary readSummary readStored parent-verdict summary
abstractExisting link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review

R03 · Kato M, Hori H, Inoue T, et al. Discontinuation of antidepressants after remission with antidepressant medication in major depressive disorder: a systematic review and meta-analysis. Mol Psychiatry. 2021;26:118-133. PMID: 32704061. DOI: 10.1038/s41380-020-0843-0.

Publisher · PubMed

Material type
Systematic review
Materials actually read
Summary read; external materials not read
Findings recorded in the stored summary
Maintenance 20.9% versus placebo switch 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001
Record level
Preserved summary; not the result of individually comparing the original texts of the two ANTLER reports
Study overlap and independent replication
NEJM and NIHR HTA reports of the same ANTLER trial share the same participants across three subclaims. The 40-study meta-analysis was not originally counted as an independent repeat of the ANTLER question; overlap among included trials and participants remains unread. Study-family identifiers link relationships and do not certify unique trial counts. Additional reports, medications, sibling questions, reviews and shared participants are not newly added as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryExisting link preservedSummary readSummary readStored parent-verdict summary
abstractExisting link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review

Report counts versus independent study counts

NEJM and NIHR HTA reports of the same ANTLER trial share the same participants across three subclaims. The 40-study meta-analysis was not originally counted as an independent repeat of the ANTLER question; overlap among included trials and participants remains unread. Study-family identifiers link relationships and do not certify unique trial counts. Additional reports, medications, sibling questions, reviews and shared participants are not newly added as independent evidence.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Have the complete-prevention claim, subclaim grade D and parent relapse-reduction grade B been kept separate?
Required materials and conditions
Separate preservation of the subclaim wording, grade and note and the parent verdict
Conditions for verification
Separate preservation of the subclaim wording, grade and note and the parent verdict
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N02 · What were the original population's remission, long-term use and consideration of discontinuation conditions?
Required materials and conditions
Age, remission, previous episodes, treatment history, eligibility and denominators
Conditions for verification
Age, remission, previous episodes, treatment history, eligibility and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N03 · Have the four antidepressants' specific study conditions been extended to all medications?
Required materials and conditions
Recording included medications, original study doses, exposure and group composition
Conditions for verification
Recording included medications, original study doses, exposure and group composition
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N04 · What was the actual comparison between maintenance and tapering to matching placebo?
Required materials and conditions
Historical interventions, placebo switching, common treatments and actual exposure
Conditions for verification
Historical interventions, placebo switching, common treatments and actual exposure
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N05 · Are the 478 randomized participants and group-specific absolute relapse denominators preserved?
Required materials and conditions
Randomization, analysis, group-specific absolute events and follow-up denominators
Conditions for verification
Randomization, analysis, group-specific absolute events and follow-up denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N06 · Does the complete-prevention claim agree with the actual maintenance-group events?
Required materials and conditions
Direct evidence for the selected duration, group, relapse definition and event counts
Conditions for verification
Direct evidence for the selected duration, group, relapse definition and event counts
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N07 · What were the relapse symptom instrument, assessment and ascertainment times?
Required materials and conditions
Instrument, episode definition, ascertainment, measurement times and group denominators
Conditions for verification
Instrument, episode definition, ascertainment, measurement times and group denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N08 · Are 39% versus 56% and the absolute 17%p difference preserved as originally recorded?
Required materials and conditions
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group
Conditions for verification
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N09 · Are the discontinuation-versus-maintenance HR direction, CI and P preserved?
Required materials and conditions
Time-to-event effect, comparison direction, CI, test and model
Conditions for verification
Time-to-event effect, comparison direction, CI, test and model
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N10 · Are the 468 participants in the primary time-to-event analysis the same denominator as the 478 for absolute relapse counts?
Required materials and conditions
Mapping relapse timing, event occurrence, complete-case exclusions and denominators
Conditions for verification
Mapping relapse timing, event occurrence, complete-case exclusions and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N11 · Are the best- and worst-case sensitivity analyses and gaps in effect magnitude retained?
Required materials and conditions
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals
Conditions for verification
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N12 · Are adherence of 70% and 52% and restarting of 39% distinguished from relapse proportions?
Required materials and conditions
Actual exposure, adherence definitions, restarting, duration and event relationships
Conditions for verification
Actual exposure, adherence definitions, restarting, duration and event relationships
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N13 · Has the magnitude of possible withdrawal-versus-relapse misclassification been established?
Required materials and conditions
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses
Conditions for verification
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N14 · Have the original modified DESS means, difference, CI and direction been kept separate?
Required materials and conditions
Withdrawal instrument, time point, group order, original difference, interval and denominators
Conditions for verification
Withdrawal instrument, time point, group order, original difference, interval and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N15 · Have matching-tablet blinding and limitations of actual allocation guesses been distinguished?
Required materials and conditions
Allocation, concealment, blinding, allocation guesses and analyst procedures
Conditions for verification
Allocation, concealment, blinding, allocation guesses and analyst procedures
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N16 · Are the prespecified first-relapse endpoint, registration and analysis hierarchy actually linked?
Required materials and conditions
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans
Conditions for verification
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N17 · Do gaps in secondary outcomes, medication or baseline-history subgroups and individual prediction remain?
Required materials and conditions
Prespecified subgroups, interactions, denominators, effects and prediction materials
Conditions for verification
Prespecified subgroups, interactions, denominators, effects and prediction materials
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N18 · Is the relationship to the other claim about 44% without relapse in discontinuation retained?
Required materials and conditions
Relationships among shared participants, relapse or non-relapse and other subclaims
Conditions for verification
Relationships among shared participants, relapse or non-relapse and other subclaims
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N19 · Has the 52-week effect been kept from extending to permanent prevention or other clinical outcomes?
Required materials and conditions
Direct outcomes including long-term follow-up, episodes, function and deaths
Conditions for verification
Direct outcomes including long-term follow-up, episodes, function and deaths
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N20 · Do Kato's 40 studies, 8,890 participants and original responses concern the same population as ANTLER?
Required materials and conditions
Review populations, post-acute maintenance, durations, denominators and trial mapping
Conditions for verification
Review populations, post-acute maintenance, durations, denominators and trial mapping
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N21 · Are review results of 20.9% maintenance versus 39.7% placebo and the OR, CI and P preserved within their original scope?
Required materials and conditions
Pooled relapse effects, group proportions, OR, intervals, tests and denominators
Conditions for verification
Pooled relapse effects, group proportions, OR, intervals, tests and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N22 · Have NEJM, the detailed NIHR report and the review been kept from being added as new independent trials?
Required materials and conditions
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions
Conditions for verification
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N23 · Have gaps in public funding, sponsorship, product supply, affiliations and external analysis been distinguished?
Required materials and conditions
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles
Conditions for verification
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N24 · Is the original information level for review funding and involvement in included trials retained?
Required materials and conditions
Review support, funding by original trial, authors and product or analysis roles
Conditions for verification
Review support, funding by original trial, authors and product or analysis roles
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N25 · Are serious-adverse-event participant counts, proportions and denominators distinguished from relapse?
Required materials and conditions
SAE definitions, participants versus events, group denominators, relatedness and exposure tables
Conditions for verification
SAE definitions, participants versus events, group denominators, relatedness and exposure tables
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N26 · Have the original duration and scope of 0 deaths or suicide attempts been distinguished from long-term absence of risk?
Required materials and conditions
Event definitions, collection, duration, exposure, denominators and rare-harm materials
Conditions for verification
Event definitions, collection, duration, exposure, denominators and rare-harm materials
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N27 · Do gaps remain in withdrawal symptoms, other maintenance-treatment harms and discontinuation applicability?
Required materials and conditions
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up
Conditions for verification
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N28 · Have repeated harms and applicability to other medications, populations and exposures been kept from new certification?
Required materials and conditions
Direct effects or harms and report relationships by population, medication and duration
Conditions for verification
Direct effects or harms and report relationships by population, medication and duration
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N29 · Are the summary, three article URLs, registration records and original-material access distinguished?
Required materials and conditions
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records
Conditions for verification
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
N30 · Are the cutoff date, languages, empty values, original verdict, candidate history and production status preserved?
Required materials and conditions
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review
Conditions for verification
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review
Requirement and applicability
Supplementary
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Referenced methods
Maintenance completely prevents relapse
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
What the statuses mean
Partly verified
Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Existing content review pending
Met
Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-11 · Public page/material version 1.0

The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Have the complete-prevention claim, subclaim grade D and parent relapse-reduction grade B been kept separate?

Current findings
The selected existing claim is ‘Maintenance completely prevents relapse’, with original grade D and a note that 39% relapsed despite maintenance. The parent concerns average relapse reduction, B with 70 points and Caution.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score, status and axes are not filled with parent values. This is not a new grade assessment.
Reason for missing information
Absent subclaim score, status and axes are not filled with parent values. This is not a new grade assessment.
Required materials and conditions
Separate preservation of the subclaim wording, grade and note and the parent verdict
Materials to obtain first
Absent subclaim score, status and axes are not filled with parent values. This is not a new grade assessment.
Further research
Proposal: Link additional materials while distinguishing complete prevention from average relapse reduction.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate preservation of the subclaim wording, grade and note and the parent verdict
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N02 · What were the original population's remission, long-term use and consideration of discontinuation conditions?

Current findings
Participants were adults who felt well enough to consider discontinuation, had at least two previous depressive episodes or at least two years of treatment, and were long-term users. The trial included 150 UK general practices.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The findings are not automatically applied to other diseases, treatment durations, remission states or populations. Detailed baseline and eligibility tables remain unread.
Reason for missing information
The findings are not automatically applied to other diseases, treatment durations, remission states or populations. Detailed baseline and eligibility tables remain unread.
Required materials and conditions
Age, remission, previous episodes, treatment history, eligibility and denominators
Materials to obtain first
The findings are not automatically applied to other diseases, treatment durations, remission states or populations. Detailed baseline and eligibility tables remain unread.
Further research
Proposal: Obtain original eligibility, baseline characteristics, remission assessment and relapse history.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Age, remission, previous episodes, treatment history, eligibility and denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N03 · Have the four antidepressants' specific study conditions been extended to all medications?

Current findings
ANTLER included users of specified doses of citalopram, fluoxetine, sertraline and mirtazapine. Original doses are preserved in the complete existing review summary.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not extend the finding to complete prevention with other medications, doses or patient groups or create instructions for taking, maintaining or discontinuing medication. Original medication-specific denominators and effects remain unread.
Reason for missing information
Do not extend the finding to complete prevention with other medications, doses or patient groups or create instructions for taking, maintaining or discontinuing medication. Original medication-specific denominators and effects remain unread.
Required materials and conditions
Recording included medications, original study doses, exposure and group composition
Materials to obtain first
Do not extend the finding to complete prevention with other medications, doses or patient groups or create instructions for taking, maintaining or discontinuing medication. Original medication-specific denominators and effects remain unread.
Further research
Proposal: Obtain medication-specific inclusion, baseline exposure, denominators and prespecified subgroup materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Recording included medications, original study doses, exposure and group composition
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N04 · What was the actual comparison between maintenance and tapering to matching placebo?

Current findings
The randomized comparison was long-term maintenance versus tapering and switching to matching placebo. The original study's 1~2-month taper is preserved only as a historical condition.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not equated with abrupt discontinuation or every discontinuation method. No new taper schedule, medication instructions or treatment substitution is created.
Reason for missing information
This is not equated with abrupt discontinuation or every discontinuation method. No new taper schedule, medication instructions or treatment substitution is created.
Required materials and conditions
Historical interventions, placebo switching, common treatments and actual exposure
Materials to obtain first
This is not equated with abrupt discontinuation or every discontinuation method. No new taper schedule, medication instructions or treatment substitution is created.
Further research
Proposal: Obtain original intervention, placebo, actual exposure, common-treatment and change materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Historical interventions, placebo switching, common treatments and actual exposure
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N05 · Are the 478 randomized participants and group-specific absolute relapse denominators preserved?

Current findings
The 478 participants were allocated to maintenance, 238, or tapering to placebo, 240. Absolute relapse counts were 92/238 versus 135/240.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Two reports of the same trial, multiple medications and other subclaims are not added as new participants.
Reason for missing information
Two reports of the same trial, multiple medications and other subclaims are not added as new participants.
Required materials and conditions
Randomization, analysis, group-specific absolute events and follow-up denominators
Materials to obtain first
Two reports of the same trial, multiple medications and other subclaims are not added as new participants.
Further research
Proposal: Obtain original participant flow, allocation, absolute event tables and missing-data mapping by group.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Randomization, analysis, group-specific absolute events and follow-up denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N06 · Does the complete-prevention claim agree with the actual maintenance-group events?

Current findings
The existing review summary and note record relapse within 52 weeks in 92/238 (39%) of the maintenance group. The preserved summary explicitly states that maintenance did not eliminate relapse.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Average reduction is not converted into complete prevention for every person or duration. No new individual prediction or guarantee is made.
Reason for missing information
Average reduction is not converted into complete prevention for every person or duration. No new individual prediction or guarantee is made.
Required materials and conditions
Direct evidence for the selected duration, group, relapse definition and event counts
Materials to obtain first
Average reduction is not converted into complete prevention for every person or duration. No new individual prediction or guarantee is made.
Further research
Proposal: Link original relapse definitions, ascertainment, events by duration and scope of individual applicability.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct evidence for the selected duration, group, relapse definition and event counts
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N07 · What were the relapse symptom instrument, assessment and ascertainment times?

Current findings
The preserved summary records relapse assessed with a depression symptom instrument as a patient-important treatment target and analyzes time to first relapse over 52 weeks.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invent an instrument name, exact diagnostic criteria, measurement schedule or assessor details absent from the original material.
Reason for missing information
Do not invent an instrument name, exact diagnostic criteria, measurement schedule or assessor details absent from the original material.
Required materials and conditions
Instrument, episode definition, ascertainment, measurement times and group denominators
Materials to obtain first
Do not invent an instrument name, exact diagnostic criteria, measurement schedule or assessor details absent from the original material.
Further research
Proposal: Obtain original relapse definitions, instrument, assessments, ascertainment times and tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Instrument, episode definition, ascertainment, measurement times and group denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N08 · Are 39% versus 56% and the absolute 17%p difference preserved as originally recorded?

Current findings
Preserve the original wording: maintenance 92/238 (39%) versus discontinuation 135/240 (56%), an absolute difference of 17%p.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new proportions, risk differences, RR, NNT, absolute-difference CI or event examples are calculated. Average reduction is not complete prevention.
Reason for missing information
No new proportions, risk differences, RR, NNT, absolute-difference CI or event examples are calculated. Average reduction is not complete prevention.
Required materials and conditions
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group
Materials to obtain first
No new proportions, risk differences, RR, NNT, absolute-difference CI or event examples are calculated. Average reduction is not complete prevention.
Further research
Proposal: Obtain original absolute-difference, CI, denominator and test materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N09 · Are the discontinuation-versus-maintenance HR direction, CI and P preserved?

Current findings
The discontinuation-versus-maintenance HR is 2.06 (95% CI 1.56~2.70), P<0.001.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invert this into a maintenance-versus-discontinuation HR or convert it into a relapse risk ratio or individual complete-protection rate. Detailed model and adjustment variables remain unread.
Reason for missing information
Do not invert this into a maintenance-versus-discontinuation HR or convert it into a relapse risk ratio or individual complete-protection rate. Detailed model and adjustment variables remain unread.
Required materials and conditions
Time-to-event effect, comparison direction, CI, test and model
Materials to obtain first
Do not invert this into a maintenance-versus-discontinuation HR or convert it into a relapse risk ratio or individual complete-protection rate. Detailed model and adjustment variables remain unread.
Further research
Proposal: Obtain the original effect of interest, HR direction, model, tests and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Time-to-event effect, comparison direction, CI, test and model
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N10 · Are the 468 participants in the primary time-to-event analysis the same denominator as the 478 for absolute relapse counts?

Current findings
The 10 participants without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis but included in absolute relapse counts. The evidence list records 468 participants in the primary analysis.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not change the absolute-event denominator to 468 or newly certify the primary analysis as an all-participant ITT analysis. No new group-specific complete-case counts are calculated.
Reason for missing information
Do not change the absolute-event denominator to 468 or newly certify the primary analysis as an all-participant ITT analysis. No new group-specific complete-case counts are calculated.
Required materials and conditions
Mapping relapse timing, event occurrence, complete-case exclusions and denominators
Materials to obtain first
Do not change the absolute-event denominator to 468 or newly certify the primary analysis as an all-participant ITT analysis. No new group-specific complete-case counts are calculated.
Further research
Proposal: Obtain original analysis populations, missing timing, group denominators and event mapping.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Mapping relapse timing, event occurrence, complete-case exclusions and denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N11 · Are the best- and worst-case sensitivity analyses and gaps in effect magnitude retained?

Current findings
The preserved summary records that sensitivity analyses using best- and worst-case assumptions remained in the same direction.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Consistent direction is not used to certify resolution of all missing-data bias, an exact effect or complete follow-up. Detailed numbers remain unread.
Reason for missing information
Consistent direction is not used to certify resolution of all missing-data bias, an exact effect or complete follow-up. Detailed numbers remain unread.
Required materials and conditions
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals
Materials to obtain first
Consistent direction is not used to certify resolution of all missing-data bias, an exact effect or complete follow-up. Detailed numbers remain unread.
Further research
Proposal: Obtain original sensitivity-analysis plans, assumptions, effects, intervals and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N12 · Are adherence of 70% and 52% and restarting of 39% distinguished from relapse proportions?

Current findings
Adherence was 70% in maintenance and 52% in discontinuation; 39% of the discontinuation group restarted a clinician-prescribed antidepressant before trial end.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not merge 39% restarting in discontinuation with 39% relapse in maintenance as the same event. No new adherer effects, reasons for restarting or denominators are calculated.
Reason for missing information
Do not merge 39% restarting in discontinuation with 39% relapse in maintenance as the same event. No new adherer effects, reasons for restarting or denominators are calculated.
Required materials and conditions
Actual exposure, adherence definitions, restarting, duration and event relationships
Materials to obtain first
Do not merge 39% restarting in discontinuation with 39% relapse in maintenance as the same event. No new adherer effects, reasons for restarting or denominators are calculated.
Further research
Proposal: Obtain original exposure, adherence, restarting, timing, event mapping and effects of interest.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Actual exposure, adherence definitions, restarting, duration and event relationships
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N13 · Has the magnitude of possible withdrawal-versus-relapse misclassification been established?

Current findings
The preserved summary states that withdrawal symptoms were greater at 12 weeks in discontinuation and possible relapse misclassification could explain some findings, but its magnitude was not established.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not assert that withdrawal explains the entire difference or newly certify that there was no misclassification.
Reason for missing information
Do not assert that withdrawal explains the entire difference or newly certify that there was no misclassification.
Required materials and conditions
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses
Materials to obtain first
Do not assert that withdrawal explains the entire difference or newly certify that there was no misclassification.
Further research
Proposal: Obtain original withdrawal and relapse definitions, timing, assessment, sensitivity and distinction analyses.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N14 · Have the original modified DESS means, difference, CI and direction been kept separate?

Current findings
At 12 weeks, modified DESS was 3.1 in discontinuation versus 1.3 in maintenance, with the original between-group difference 1.9 (95% CI 1.5~2.3).
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not subtract the means again to revise the recorded difference or convert it into a new P, CI, denominator or relapse count. Adjustment and instrument definitions remain unread.
Reason for missing information
Do not subtract the means again to revise the recorded difference or convert it into a new P, CI, denominator or relapse count. Adjustment and instrument definitions remain unread.
Required materials and conditions
Withdrawal instrument, time point, group order, original difference, interval and denominators
Materials to obtain first
Do not subtract the means again to revise the recorded difference or convert it into a new P, CI, denominator or relapse count. Adjustment and instrument definitions remain unread.
Further research
Proposal: Obtain original DESS measurements, model, recorded difference, group denominators and repeated time points.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Withdrawal instrument, time point, group order, original difference, interval and denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N15 · Have matching-tablet blinding and limitations of actual allocation guesses been distinguished?

Current findings
The existing review summary records a double-blind trial using matching tablets, but discontinuation participants guessed allocation better.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Nominal blinding alone does not certify complete actual blinding or resolution of all bias. Guessing proportions and allocation-concealment details remain unread.
Reason for missing information
Nominal blinding alone does not certify complete actual blinding or resolution of all bias. Guessing proportions and allocation-concealment details remain unread.
Required materials and conditions
Allocation, concealment, blinding, allocation guesses and analyst procedures
Materials to obtain first
Nominal blinding alone does not certify complete actual blinding or resolution of all bias. Guessing proportions and allocation-concealment details remain unread.
Further research
Proposal: Obtain original blinding, guessing, allocation, measurement and analysis procedures.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Allocation, concealment, blinding, allocation guesses and analyst procedures
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N16 · Are the prespecified first-relapse endpoint, registration and analysis hierarchy actually linked?

Current findings
The evidence-list endpoint is time to first relapse over 52 weeks, and the registration identifiers are ISRCTN15969819 · EudraCT2015-004210-26.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new registration or SAP reading or registration URL construction is performed. Complete prevention is not created as a separate prespecified endpoint of the original trial.
Reason for missing information
No new registration or SAP reading or registration URL construction is performed. Complete prevention is not created as a separate prespecified endpoint of the original trial.
Required materials and conditions
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans
Materials to obtain first
No new registration or SAP reading or registration URL construction is performed. Complete prevention is not created as a separate prespecified endpoint of the original trial.
Further research
Proposal: Obtain original registration, plans, analysis hierarchy and change history.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N17 · Do gaps in secondary outcomes, medication or baseline-history subgroups and individual prediction remain?

Current findings
The preserved summary states that the trial did not identify who could discontinue safely.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not create universal protection with maintenance, individual safe discontinuation, medication rankings or baseline-history effects.
Reason for missing information
Do not create universal protection with maintenance, individual safe discontinuation, medication rankings or baseline-history effects.
Required materials and conditions
Prespecified subgroups, interactions, denominators, effects and prediction materials
Materials to obtain first
Do not create universal protection with maintenance, individual safe discontinuation, medication rankings or baseline-history effects.
Further research
Proposal: Obtain original subgroup, interaction, individual-prediction and secondary-outcome plans and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Prespecified subgroups, interactions, denominators, effects and prediction materials
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N18 · Is the relationship to the other claim about 44% without relapse in discontinuation retained?

Current findings
The existing review summary and sibling subclaim preserve the wording that 44% of the discontinuation group did not relapse within 52 weeks.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This value is not newly calculated or converted into advice that every person can or cannot discontinue safely.
Reason for missing information
This value is not newly calculated or converted into advice that every person can or cannot discontinue safely.
Required materials and conditions
Relationships among shared participants, relapse or non-relapse and other subclaims
Materials to obtain first
This value is not newly calculated or converted into advice that every person can or cannot discontinue safely.
Further research
Proposal: Link the two subclaims while retaining their relationship to the same trial, duration and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relationships among shared participants, relapse or non-relapse and other subclaims
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N19 · Has the 52-week effect been kept from extending to permanent prevention or other clinical outcomes?

Current findings
The selected original materials' central duration is 52 weeks, and maintenance participants also relapsed.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The 52-week reduction is not extended to lifelong absence of relapse, function, quality of life, survival or treatment benefit for every disease.
Reason for missing information
The 52-week reduction is not extended to lifelong absence of relapse, function, quality of life, survival or treatment benefit for every disease.
Required materials and conditions
Direct outcomes including long-term follow-up, episodes, function and deaths
Materials to obtain first
The 52-week reduction is not extended to lifelong absence of relapse, function, quality of life, survival or treatment benefit for every disease.
Further research
Proposal: Obtain direct relapse, clinical-function and long-term outcome materials separately by duration.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct outcomes including long-term follow-up, episodes, function and deaths
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N20 · Do Kato's 40 studies, 8,890 participants and original responses concern the same population as ANTLER?

Current findings
Kato pooled 40 studies and 8,890 participants from varied post-acute-treatment maintenance-versus-placebo-switch trials.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not treated as the same direct comparison as the real discontinuation decision among long-term primary-care users. Populations, durations and overlap by included trial remain unread.
Reason for missing information
This is not treated as the same direct comparison as the real discontinuation decision among long-term primary-care users. Populations, durations and overlap by included trial remain unread.
Required materials and conditions
Review populations, post-acute maintenance, durations, denominators and trial mapping
Materials to obtain first
This is not treated as the same direct comparison as the real discontinuation decision among long-term primary-care users. Populations, durations and overlap by included trial remain unread.
Further research
Proposal: Obtain the review's original eligibility, included trials, durations, denominators and relationship to ANTLER.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Review populations, post-acute maintenance, durations, denominators and trial mapping
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R03

N21 · Are review results of 20.9% maintenance versus 39.7% placebo and the OR, CI and P preserved within their original scope?

Current findings
The review reports maintenance 20.9% versus placebo switch 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Maintenance 20.9% also does not mean complete prevention. The original OR is not converted into ANTLER's HR or an individual protection rate. No new proportions or differences are calculated.
Reason for missing information
Maintenance 20.9% also does not mean complete prevention. The original OR is not converted into ANTLER's HR or an individual protection rate. No new proportions or differences are calculated.
Required materials and conditions
Pooled relapse effects, group proportions, OR, intervals, tests and denominators
Materials to obtain first
Maintenance 20.9% also does not mean complete prevention. The original OR is not converted into ANTLER's HR or an individual protection rate. No new proportions or differences are calculated.
Further research
Proposal: Obtain original pooled models, trial-specific effects, denominators, definitions and heterogeneity.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Pooled relapse effects, group proportions, OR, intervals, tests and denominators
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R03

N22 · Have NEJM, the detailed NIHR report and the review been kept from being added as new independent trials?

Current findings
NEJM and NIHR HTA are two reports of the same ANTLER trial. The preserved summary states that the review supports the same direction but was not counted as an independent repeat of the ANTLER question.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Reports, medications, subclaims and the review's 40 studies are not added as new independent trials or participants. Final independent counts and total participant sums remain unrecorded.
Reason for missing information
Reports, medications, subclaims and the review's 40 studies are not added as new independent trials or participants. Final independent counts and total participant sums remain unrecorded.
Required materials and conditions
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions
Materials to obtain first
Reports, medications, subclaims and the review's 40 studies are not added as new independent trials or participants. Final independent counts and total participant sums remain unrecorded.
Further research
Proposal: Link additional reports through original identifiers and preserve relationships among shared populations and included trials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02 R03

N23 · Have gaps in public funding, sponsorship, product supply, affiliations and external analysis been distinguished?

Current findings
Preserve NIHR HTA 13/115/48, PRIMENT NIHR core support and UCL sponsorship. The preserved summary records that donated trial medication or placebo from a pharmaceutical company was not described in the NEJM or NIHR reports.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original non-reporting is not converted into certification of no donated supply. Detailed company affiliations and external-analysis roles remain unread.
Reason for missing information
Original non-reporting is not converted into certification of no donated supply. Detailed company affiliations and external-analysis roles remain unread.
Required materials and conditions
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles
Materials to obtain first
Original non-reporting is not converted into certification of no donated supply. Detailed company affiliations and external-analysis roles remain unread.
Further research
Proposal: Obtain original support, supply, affiliations, research roles and analysis disclosures separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N24 · Is the original information level for review funding and involvement in included trials retained?

Current findings
The existing review summary records Japanese Ministry of Health, Labour and Welfare grants H29-SEISHIN-ippan-001 and 19GC1012 for the review.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Review support is not extended to certification that all 40 included studies had public funding, independence or no product supply.
Reason for missing information
Review support is not extended to certification that all 40 included studies had public funding, independence or no product supply.
Required materials and conditions
Review support, funding by original trial, authors and product or analysis roles
Materials to obtain first
Review support is not extended to certification that all 40 included studies had public funding, independence or no product supply.
Further research
Proposal: Obtain original review and trial-specific support, affiliations, products and analysis relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Review support, funding by original trial, authors and product or analysis roles
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R03

N25 · Are serious-adverse-event participant counts, proportions and denominators distinguished from relapse?

Current findings
Original safety information records serious adverse events in 9 maintenance participants (4%) versus 8 discontinuation participants (3%).
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not convert these into event counts, medication-related harms or statistically significant safety differences. No new differences, P, CI or proportions are calculated. Denominator, collection and relatedness details remain unread.
Reason for missing information
Do not convert these into event counts, medication-related harms or statistically significant safety differences. No new differences, P, CI or proportions are calculated. Denominator, collection and relatedness details remain unread.
Required materials and conditions
SAE definitions, participants versus events, group denominators, relatedness and exposure tables
Materials to obtain first
Do not convert these into event counts, medication-related harms or statistically significant safety differences. No new differences, P, CI or proportions are calculated. Denominator, collection and relatedness details remain unread.
Further research
Proposal: Obtain original SAE definitions, group-specific events and participants, denominators, relatedness, exposure and discontinuation.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
SAE definitions, participants versus events, group denominators, relatedness and exposure tables
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N26 · Have the original duration and scope of 0 deaths or suicide attempts been distinguished from long-term absence of risk?

Current findings
Original safety information records 0 deaths and suicide attempts in both groups.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Zero events are not extended to absence of every rare harm, long-term safety or longevity benefit. No new risk CI or numerical examples are created.
Reason for missing information
Zero events are not extended to absence of every rare harm, long-term safety or longevity benefit. No new risk CI or numerical examples are created.
Required materials and conditions
Event definitions, collection, duration, exposure, denominators and rare-harm materials
Materials to obtain first
Zero events are not extended to absence of every rare harm, long-term safety or longevity benefit. No new risk CI or numerical examples are created.
Further research
Proposal: Obtain original event collection, exposure, denominators, duration and long-term rare-harm materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Event definitions, collection, duration, exposure, denominators and rare-harm materials
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N27 · Do gaps remain in withdrawal symptoms, other maintenance-treatment harms and discontinuation applicability?

Current findings
The preserved summary records increased withdrawal symptoms 12 weeks after discontinuation and possible misclassification of some relapse events. The parent safety status is Caution.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Withdrawal is not wholly equated with relapse or maintenance-medication harm. No long-term harm rates or maintenance or discontinuation instructions outside the original materials are created.
Reason for missing information
Withdrawal is not wholly equated with relapse or maintenance-medication harm. No long-term harm rates or maintenance or discontinuation instructions outside the original materials are created.
Required materials and conditions
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up
Materials to obtain first
Withdrawal is not wholly equated with relapse or maintenance-medication harm. No long-term harm rates or maintenance or discontinuation instructions outside the original materials are created.
Further research
Proposal: Obtain original withdrawal, maintenance-medication harm, exposure, discontinuation and long-term materials separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02

N28 · Have repeated harms and applicability to other medications, populations and exposures been kept from new certification?

Current findings
Current materials compare maintenance with tapering to placebo among particular long-term users in remission; the review concerns varied maintenance trials.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not advise an individual to maintain, discontinue, taper or restart medication or certify complete prevention or safety for all medications and populations.
Reason for missing information
Do not advise an individual to maintain, discontinue, taper or restart medication or certify complete prevention or safety for all medications and populations.
Required materials and conditions
Direct effects or harms and report relationships by population, medication and duration
Materials to obtain first
Do not advise an individual to maintain, discontinue, taper or restart medication or certify complete prevention or safety for all medications and populations.
Further research
Proposal: Link direct comparisons and harm materials for new populations, medications and exposures separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct effects or harms and report relationships by population, medication and duration
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02 R03

N29 · Are the summary, three article URLs, registration records and original-material access distinguished?

Current findings
The complete parent verdict summary was read for production, and three PubMed URLs, original DOIs and registration strings were linked.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new URLs are constructed from identifiers. External abstracts, full texts, registrations, protocols and SAP remain unread, with no separate link test.
Reason for missing information
No new URLs are constructed from identifiers. External abstracts, full texts, registrations, protocols and SAP remain unread, with no separate link test.
Required materials and conditions
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records
Materials to obtain first
No new URLs are constructed from identifiers. External abstracts, full texts, registrations, protocols and SAP remain unread, with no separate link test.
Further research
Proposal: Link original materials supplied by the user with individual types and actual access status.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02 R03

N30 · Are the cutoff date, languages, empty values, original verdict, candidate history and production status preserved?

Current findings
Preserve 2026-08-26, empty correction and deliberation values, Korean and English drafts, parent B70, Caution and axes, and subclaim grade D. Original review-pending and production-eligibility markers are historical records.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim scores are not filled. Existing content review remains incomplete; review-pending activation and completion markers are false, new units are 0 and the final independent total is unrecorded.
Reason for missing information
Absent subclaim scores are not filled. Existing content review remains incomplete; review-pending activation and completion markers are false, new units are 0 and the final independent total is unrecorded.
Required materials and conditions
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review
Materials to obtain first
Absent subclaim scores are not filled. Existing content review remains incomplete; review-pending activation and completion markers are false, new units are 0 and the final independent total is unrecorded.
Further research
Proposal: Reflect additional materials and decisions through preservation of original wording and separate events.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review
Why this condition is needed
Individual production condition recording the selected claim, original events, denominators, duration and interpretive boundaries
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Maintenance completely prevents relapse

Related sources R01 R02 R03