Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration

Marc B. Stone · THOMAS P. LAUGHREN · Mark S Levenson · P C. Holland · Tarek A. Hammad · Robert Temple

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Suicide and Self-Harm Studies Pharmacovigilance and Adverse Drug Reactions Treatment of Major Depression

Abstract

OBJECTIVE: To examine the risk of suicidal behaviour within clinical trials of antidepressants in adults. DESIGN: Meta-analysis of 372 double blind randomised placebo controlled trials. SETTING: Drug development programmes for any indication in adults. PARTICIPANTS: 99 231 adults assigned to antidepressants or placebo. Median age was 42 and 63.1% were women. Indications for treatment were major depression (45.6%), other depression (4.6%), other psychiatric disorders (27.6%), and non-psychiatric disorders (22.2%). MAIN OUTCOME MEASURES: Suicidal behaviour (completed suicide, attempted suicide, or preparatory acts) and ideation. RESULTS: For participants with non-psychiatric indications, suicidal behaviour and ideation were extremely rare. For those with psychiatric indications, risk was associated with age. For suicidal behaviour or ideation and for suicidal behaviour only, the respective odds ratios were 1.62 (95% confidence interval 0.97 to 2.71) and 2.30 (1.04 to 5.09) for participants aged <25, 0.79 (0.64 to 0.98) and 0.87 (0.58 to 1.29) for those aged 25-64, and 0.37 (0.18 to 0.76) and 0.06 (0.01 to 0.58) for those aged >or=65. When age was modelled as a continuous variable, the odds ratio for suicidal behaviour or ideation declined at a rate of 2.6% per year of age (-3.9% to -1.3%, P=0.0001) and the odds ratio for suicidal behaviour declined at a rate of 4.6% per year of age (-7.4% to -1.8%, P=0.001). CONCLUSIONS: Risk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents. The net effect seems to be neutral on suicidal behaviour but possibly protective for suicidal ideation in adults aged 25-64 and to reduce the risk of both suicidality and suicidal behaviour in those aged >or=65.

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References

2000Methods for Meta-Analysis in Medical Research 2006Suicidality in Pediatric Patients Treated With Antidepressant Drugs 2007Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants

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2021Improving Suicide Prevention Through Evidence-Based Strategies: A Systematic Review 2011Suicide in Older Adults 2011The European Psychiatric Association (EPA) guidance on suicide treatment and prevention 2016Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports 2015Suicide risk assessment and intervention in people with mental illness 2015Antidepressant use and risk of suicide and attempted suicide or self harm in people aged 20 to 64: cohort study using a primary care database 2017Neuropathology of suicide: recent findings and future directions 2013Prediction of Suicidal Behavior in Clinical Research by Lifetime Suicidal Ideation and Behavior Ascertained by the Electronic Columbia-Suicide Severity Rating Scale

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