Evidence map›Paper›PMID 42463208›Full record

ArticleBMJ open2026

Safe discontinuation of antidepressants in individuals with clinically remitted depressive disorders: study protocol for a randomised controlled trial.

Giovanni Ostuzzi, Chiara Gastaldon, Debora Zaccoletti, Francesco Bartoli, Giulia Belnome, Giuseppe Carrà, Simone Cavallotti, Ioana Cristea, Armando D'Agostino, Pasquale De Fazio and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07393919 (Safe Discontinuation of Antidepressants in Individuals With Clinically Remitted Depressive Disorders), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT07393919 phase4not yet recruitingnot on this map

Safe Discontinuation of Antidepressants in Individuals With Clinically Remitted Depressive Disorders

TypeinterventionalSponsorUniversita di VeronaRan2026 to 2027Enrolled150ConditionsDepression - Major Depressive DisorderArmsHyperbolic tapering, Linear tapering
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Giovanni OstuzziWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy giovanni.ostuzzi@univr.it.ORCID http://orcid.org/0000-0003-2248-9524
Chiara GastaldonWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Debora ZaccolettiWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Francesco BartoliSchool of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
Giulia BelnomeWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Giuseppe CarràSchool of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
Simone CavallottiDepartment of Mental Health and Addiction, ASST Santi Paolo e Carlo, Milan, Italy.
Ioana CristeaDepartment of General Psychology, University of Padua, Padua, Italy.
Armando D'AgostinoDepartment of Mental Health and Addiction, ASST Santi Paolo e Carlo, Milan, Italy.ORCID http://orcid.org/0000-0002-2126-799X
Pasquale De FazioDepartment of Health Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.
Renato de FilippisDepartment of Health Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.
Carolina GottardiWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Caterina NovaraDepartment of General Psychology, University of Padua, Padua, Italy.
Davide PapolaWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Ilaria RiboldiSchool of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
Federico TedeschiWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Francesco AmaddeoWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Corrado BarbuiWHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAntidepressant overprescribing and unnecessary long-term use are common and can increase the risk of adverse effects and withdrawal symptoms on discontinuation. Although gradual tapering strategies have been proposed, empirical evidence from randomised trials is lacking. This study will compare the efficacy of two antidepressant discontinuation strategies-linear and hyperbolic tapering-in adults with remitted depressive disorders. METHODS AND ANALYSIS: This pragmatic, multicentre, open-label, parallel-group superiority randomised controlled trial will recruit adults (≥18 years) with remitted depressive disorders who have been taking an antidepressant for at least 6 months. During an 8-month recruitment period, participants in outpatient psychiatric and primary care settings will be randomised (1:1) to (a) linear tapering (dose reduced by 50% of the minimum effective dose every 2 weeks until cessation) or (b) hyperbolic tapering (dose reduced by 20-25% every 2 weeks until cessation). The primary outcome is the proportion of participants who fail to discontinue the antidepressant by the end of the predefined tapering schedule or who re-initiate antidepressant therapy within 16 weeks of discontinuation. Secondary outcomes include safety, tolerability (including withdrawal symptoms), acceptability, clinical effectiveness, social functioning, quality of life and cost-effectiveness. Recruiters and participants will be aware of their treatment allocation; however, outcome assessors and the biostatistician will remain blinded throughout follow-up. Validated rating scales measuring depression, anxiety, withdrawal symptoms and social functioning will be administered at baseline and at scheduled follow-up visits up to 36 weeks. Based on observational data, we aim to recruit 150 participants (75 per arm). ETHICS AND DISSEMINATION: The study was approved by institutional Ethics Committees and regulatory authorities. Written informed consent will be obtained from all participants and data processed in accordance with General Data Protection Regulation. Study insurance and pharmacovigilance procedures are in place. Findings will be published in open-access journals, presented at scientific meetings and communicated to policy and regulatory stakeholders.

trial registrationNCT07393919.

Indexed as

Antidepressive AgentsDepressive DisorderDrug TaperingSubstance Withdrawal SyndromeAdultEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment InterruptionAntidepressive AgentsAdult psychiatryDepression & mood disordersPrimary Health CareQuality of LifeRandomized Controlled Trial

Identifiers

PMID42463208
PMCPMC13374453

What OpenQuestion holds

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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.