Evidence map›Paper›PMID 39920066›Full record

SynthesisBMJ open2025

Beneficial and harmful effects of duloxetine versus placebo, 'active placebo' or no intervention for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.

Faiza Siddiqui, Johanne Juul Petersen, Sophie Juul, Caroline Barkholt Kamp, Marija Barbateskovic, Joanna Moncrieff, Mark Abie Horowitz, Mathias Maagaard, Kiran Kumar Katakam, Christian Gluud and 1 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

11 authors.

Faiza SiddiquiCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark faiza.siddiqui@ctu.dk.ORCID 0000-0002-8358-6259
Johanne Juul PetersenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-9837-1958
Sophie JuulCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-6171-2904
Caroline Barkholt KampCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-7756-4694
Marija BarbateskovicCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-8566-3660
Joanna MoncrieffDivision of Psychiatry, University College London, London, UK.ORCID 0000-0003-1214-6974
Mark Abie HorowitzResearch and Development Department, North East London NHS Foundation Trust (NELFT), Essex, UK.ORCID 0000-0003-1318-2029
Mathias MaagaardCentre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Kiran Kumar KatakamCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-8861-0799
Janus C JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the beneficial and harmful effects of duloxetine versus 'active placebo', placebo or no intervention for adults with major depressive disorder.

designSystematic review with meta-analysis and trial sequential analysis of randomised trials. DATA SOURCES: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and other relevant databases up until January 2023. We requested clinical study reports from 36 competent authorities. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: All randomised clinical trials comparing duloxetine versus placebo, 'active placebo' or no intervention, irrespective of publication type, publication status, publication year and language for treatment of major depressive disorder in adults. DATA EXTRACTION AND SYNTHESIS: Five authors in pairs extracted data using a standardised data extraction sheet. A third review author was consulted for disagreements. Intervention effects were assessed by both random-effects and fixed-effect model meta-analyses, risk of bias assessments were performed by two independent review authors using Cochrane's risk of bias tool V.2 and the certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.

resultsWe included 28 trials randomising a total of 7872 participants. All results were at high risk of bias. The trials' assessment time points were between 6 and 16 weeks after randomisation. Meta-analyses showed evidence of a beneficial effect of duloxetine on depressive symptoms (mean difference -1.81, Hamilton Depression Rating Scale (HDRS-17) points; 95% CI -2.34 to -1.28; heterogeneity I

conclusionsDuloxetine appears to reduce depressive symptom scores and improve quality of life scores in the short term, but the effect sizes are minimal and of questionable patient importance. The short- and long-term effects of duloxetine on risks of SAEs and suicidality are uncertain. Duloxetine increases the risks of several short-term adverse events. Systematic assessments of benefits and harms over longer periods are required. TRIAL REGISTRATION NUMBER: PROSPERO 2016 CRD42016053931.

Indexed as

Antidepressive AgentsDuloxetine HydrochlorideMajor Depressive DisorderAdultHumansRandomized Controlled Trials as TopicAntidepressive AgentsDuloxetine HydrochlorideMeta-AnalysisPSYCHIATRYSystematic Review

Identifiers

PMID39920066
PMCPMC12056638

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.