Placebo effect in randomized, controlled studies of acute bipolar mania and depression

Randomized, double-blind, placebo-controlled parallel group clinical trials have been the standard methodology for establishing the efficacy of new tr eatments for patients with bipolar disorder in manic, mixed, or depressive episodes. We examine the placebo response rate in acute treatment trials of acute mania (and mixed states) and bipolar depression. Also addressed are potential variables associated with placebo response, strategies to minimiz e placebo response the optimum duration of placebo-controlled acute treatme nt trials, possible alternatives to the use of placebo, and the ramificatio ns of these issues with regard to the design of studies in children, adoles cents, and older adults with bipolar disorder. (C) 2000 Society of Biologic al Psychiatry.