ReviewJournal of clinical and translational science2017
Maintenance efficacy designs in psychiatry: Randomized discontinuation trials - enriched but not better.
Review in Journal of clinical and translational science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Impact of treatment duration on the effectiveness of opioid analgesia: a systematic review and meta-analysis.The British journal of general practice : the journal of the Royal College of General Practitioners · 2026Pooled it
- Methodological considerations for analyzing enriched enrolment randomized withdrawal trials.Clinics (Sao Paulo, Brazil) · 2026Article
- Testing the internal validity of the maintenance/discontinuation study design for antidepressant medications in depression using simulations.medRxiv : the preprint server for health sciences · 2025Article
- Prophylactic effects or withdrawal reactions? An analysis of time-to-event data from antidepressant relapse prevention trials submitted to the FDA.Therapeutic advances in psychopharmacology · 2021Article
- How effective are antidepressants for depression over the long term? A critical review of relapse prevention trials and the issue of withdrawal confounding.Therapeutic advances in psychopharmacology · 2020Review
- Withdrawal effects confounding in clinical trials: another sign of a needed paradigm shift in psychopharmacology research.Therapeutic advances in psychopharmacology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
introductionAlthough classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called "enriched" trials, are used increasingly, especially in psychiatric maintenance studies.
methodsA narrative review of two decades of experience with RDTs.
resultsRDTs in psychiatric maintenance trials tend to use a dependent variable as a predictor: treatment response. Treatment responders are assessed for treatment response. This tautology in the logic of RDTs renders them invalid, since the predictor and the outcome are the same variable. Although RDTs can be designed to avoid this tautologous state of affairs, like using independent predictors of outcomes, such is not the case with psychiatric maintenance studies Further, purported benefits of RDTs regarding feasibility were found to be questionable. Specifically, RDTs do not enhance statistical power in many settings, and, because of high dropout rates, produce results of questionable validity. Any claimed benefits come with notably reduced generalizability.
conclusionsRDTs appear to be scientifically invalid as used in psychiatric maintenance designs. Their purported feasibility benefits are not seen in actual trials for psychotropic drugs. There is warrant for changes in federal policy regarding marketing indications for maintenance efficacy using the RDT design.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.