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

• Published in: BMJ 2009-08, Vol.339 (7718), p.431-434
• Main Authors: Stone, Marc, Laughren, Thomas, Jones, M Lisa, Levenson, Mark, Holland, P Chris, Hughes, Alice, Hammad, Tarek A, Temple, Robert, Rochester, George
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adults; Age; Aged; Aged, 80 and over; Antidepressant drugs; Antidepressants; Antidepressive Agents - adverse effects; Child and Adolescent Psychiatry; Child and Adolescent Psychiatry (Paedatrics); Clinical trials; Clinical Trials (Epidemiology); Depression; Depressive Disorder - drug therapy; Depressive Disorder - psychology; Depressive disorders; Double-Blind Method; Drugs: Musculoskeletal and Joint Diseases; Female; Humans; Ideation; Major depressive disorder; Male; Medicines Regulation; Middle Aged; Mood Disorders (Including Depression); Placebos; Randomized Controlled Trials as Topic; Risk Factors; Suicidal behaviour; Suicidal ideation; Suicide; Suicide (Psychiatry); Suicide (Public Health); Suicide - psychology; Suicide - statistics & numerical data; Suicide, Attempted - psychology; Suicide, Attempted - statistics & numerical data; United States; United States Food and Drug Administration; Young Adult
• ISSN: 0959-8138; 0959-535X; 1468-5833; 1756-1833
• DOI: 10.1136/bmj.b2880

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