Suicide Risk in Placebo-Controlled Trials of Treatment for Acute Manic Episode and Prevention of Manic-Depressive Episode

All placebo-controlled, double-blind, randomized trials of medication for the treatment of acute manic episode & the prevention of manic/depressive episode that were part of a registration dossier submitted to the Medicines Evaluation Board in the Netherlands were reviewed for occurrence of suicide & attempted suicide. A greater risk of suicide or attempted suicide was found in the placebo group. The authors caution that this finding should not be an argument against the conduct of placebo-controlled trials provided appropriate precautions are taken. (19 refs.)