Citalopram and suicidality in adult major depression and anxiety disorders.
The suicide-related data on citalopram from controlled clinical trials in depression and anxiety disorders were analysed. Safety data from placebo-controlled and relapse prevention citalopram trials in depression/major depressive disorder (MDD) and anxiety were searched for specific events relating to fatal suicide, non-fatal self-harm or suicidal thoughts. Efficacy data (item 10, suicidal thoughts, on the Montgomery-Asberg Depression Rating Scale [MADRS]) were also analysed. In the clinical trial database, the number of adverse events (fatal suicide, non-fatal self-harm or suicidal thoughts) was low, both during the first 2 weeks of treatment and during the full treatment period, with no statistically significant differences between citalopram and placebo. There was one fatal suicide during treatment (after 12 weeks of double-blind treatment in a relapse-prevention trial) for a patient treated with citalopram (incidence: 0.4%; rate: 0.010) and none on placebo. Citalopram was significantly more efficacious than placebo in lowering suicidal thoughts, based on efficacy rating (MADRS, item 10). There was no indication from this review of clinical trial data that citalopram may increase the risk of suicide in patients with MDD or anxiety. However, the patients in these clinical trials represent a selected group, as those patients with a significant risk of suicide were excluded at trial onset.
Pedersen
Anders G
AG
Drug Development, H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby Copenhagen, Denmark. AGPE@lundbeck.com
D016907:Adverse Drug Reaction Reporting Systems; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects* / Q000627:therapeutic use; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D015283:Citalopram / Q000009:adverse effects* / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D013405:Suicide / Q000523:psychology* / Q000706:statistics & numerical data; D013406:Suicide, Attempted / Q000523:psychology* / Q000706:statistics & numerical data
D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram