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.

To evaluate the safety and efficacy of risperidone monotherapy for acute mania.

In a 3-week, randomised, double-blind trial, 290 in-patients with bipolar l 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.

Risperidone was received by 146 patients and placebo by 144. Their mean baselineYMRS score was 37. 2 (s. e. =0. 5). Significantly greater improvements were observed with risperidone than with placebo at weeks l and 2 and at end-point (total YMRS: P<0. 01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.

In patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania.

To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania.

Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76).

Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P < 0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups.

Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.