Risperidone in the treatment of acute mania - Double-blind, placebo-controlled study

Background Severe mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed. Aims To evaluate the safety and efficacy of risperidone monotherapy for acute mania. Method In a 3-week, randomised, double-blind trial, 290 in-patients with bipolar I disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1-6 mg per day) or placebo. Results Risperidone was received by 146 patients and placebo by 144. Their mean baseline YMRS score was 37.2 (s.e.=0.5). Significantly greater improvements were observed with risperidone than with placebo at weeks 1 and 2 and at end-point (total YMRS: P < 0.0 1). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group. Conclusions Inpatients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week I and substantial changes at end - point. Treatment was well tolerated. Declaration of interest B.L., F.G., M.E. and M.K. are employees of Johnson & Johnson Pharmaceutical Research and Development, which supported this study.