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Cited by 510Suicide and Self-Harm StudiesTreatment of Major DepressionElectroconvulsive Therapy Studies

Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials

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Fergusson, Dean, Doucette, Steve, Glass, Kathleen Cranley, Shapiro, Stan, Healy, David, Hebert, Paul, Hutton, Brian·2005·BMJ
DOI 10.1136/bmj.330.7488.396PMC PMC549110
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Abstract

OBJECTIVE: To establish whether an association exists between use of selective serotonin reuptake inhibitors (SSRIs) and suicide attempts. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Medline and the Cochrane Collaboration's register of controlled trials (November 2004) for trials produced by the Cochrane depression, anxiety, and neurosis group. SELECTION OF STUDIES: Studies had to be randomised controlled trials comparing an SSRI with either placebo or an active non-SSRI control. We included clinical trials that evaluated SSRIs for any clinical condition. We excluded abstracts, crossover trials, and all trials whose follow up was less than one week. RESULTS: Seven hundred and two trials met our inclusion criteria. A significant increase in the odds of suicide attempts (odds ratio 2.28, 95% confidence 1.14 to 4.55, number needed to treat to harm 684) was observed for patients receiving SSRIs compared with placebo. An increase in the odds ratio of suicide attempts was also observed in comparing SSRIs with therapeutic interventions other than tricyclic antidepressants (1.94, 1.06 to 3.57, 239). In the pooled analysis of SSRIs versus tricyclic antidepressants, we did not detect a difference in the odds ratio of suicide attempts (0.88, 0.54 to 1.42). DISCUSSION: Our systematic review, which included a total of 87 650 patients, documented an association between suicide attempts and the use of SSRIs. We also observed several major methodological limitations in the published trials. A more accurate estimation of risks of suicide could be garnered from investigators fully disclosing all events.

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  • Both pediatric and adult studies of antidepressant effects on suicidal behavior show reductions in suicidal behavior in meta-analyses more readily than in individual RCTs.

    “Both pediatric and adult studies of antidepressant effects on suicidal behavior show reductions in suicidal behavior in meta-analyses, more readily than in individual RCTs, probably because the low base rate of suicide attempts requires larger sample sizes.”

    From Improving Suicide Prevention Through Evidence-Based Strategies: A Systematic Review (2021) · cites this paper as [53]

    The Results report the opposite direction for the paper’s pooled analysis: SSRIs significantly increased suicide attempts compared with placebo, rather than reducing them. The Introduction notes that rare events can make differences hard to detect in individual studies, but its mention of an earlier reduction concerns suicidal ideation, not suicidal behavior. (LLM, conf=0.91)

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  • Seventeen pharmacotherapy trials with suicidal behavior as an outcome, including twelve adult studies, five pediatric studies, and seven RCT meta-analyses, have appeared since the FDA adopted black box warnings in 2004 and 2006.

    “Seventeen pharmacotherapy trials with suicidal behavior as an outcome (Table S2a), including twelve studies in adults, five pediatric studies and seven RCT meta-analyses(48–54), have appeared since the FDA(51) adopted black box warnings in 2004 and 2006 regarding psychotropic medication-related suicide risk in children and young adults, respectively.”

    From Improving Suicide Prevention Through Evidence-Based Strategies: A Systematic Review (2021) · cites this paper as [53]

    The Methods and Results identify this paper as a systematic review and meta-analysis of randomized trials assessing suicide attempts, so it supports its inclusion as one of the cited RCT meta-analyses. The Introduction mentions FDA advisories, but the paper does not establish the stated counts of 17 trials, 12 adult studies, five pediatric studies, and seven meta-analyses. Published in February 2005, it also cannot substantiate a 2006 FDA warning. (LLM, conf=0.85)

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Research works printed but not linked: 2

  1. [16]16. Alderson P, Green S, Higgins JPT, eds. Cochrane reviewers' handbook 4.2.2 [updated December 2003]. Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley.
  2. [17]17. Deeks J, Bradburn M, Bilker W, Localio R, Berlin J. Much ado about nothing: statistical methods for meta-analysis with rare events. Proceedings of the Sixth Cochrane Collo- quium, Baltimore, USA, 1998:50.

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Authors
Fergusson, D., Doucette, S., Glass, K. C., Shapiro, S., Healy, D., Hebert, P., & Hutton, B.
Affiliations
  • McGill University (CA)
  • Bangor University (GB)
Corresponding author
Fergusson, Dean
ORCID
Venue
BMJ
Publisher
BMJ
Published
2005-02-17
Volume
330
Issue
7488
Pages
396
ISSN
  • 0007-1447 (ISSN-L)
  • 0959-8138
  • 1468-5833
DOI
10.1136/bmj.330.7488.396
PMC
PMC549110
OpenAlex
W2124353882
Cited by
510
References
21
Citations by year
2026: 6 · 2025: 7 · 2024: 15 · 2023: 12 · 2022: 9 · 2021: 11 · 2020: 16 · 2019: 13 · 2018: 16 · 2017: 16 · 2016: 28 · 2015: 20 · 2014: 23 · 2013: 21 · 2012: 24
FWCI
9.66
Type
journal article
Language
en
Open access
Licence
www.bmj.org/licenses/tdm/1.0/terms-and-conditions.html (tdm)
Locations
  • BMJ (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
Keywords
suicide attempts, selective serotonin reuptake inhibitors, antidepressant safety, tricyclic antidepressants, adverse drug reactions, depression treatment
MeSH terms
Adult, Aged, Depressive Disorder, Female, Humans, Male, Middle Aged, Prognosis, Suicide, Attempted, Odds Ratio, Randomized Controlled Trials as Topic, Selective Serotonin Reuptake Inhibitors

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