Mood stabilisers plus risperidone or placebo in the treatment of acute mania - International, double-blind, randomised controlled trial

Background Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania. Aims To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania. Method Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76). Results Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week I 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 v as similar in both groups. Conclusions Risperidone is superior placebo when used in combination with lithium or divalproex in acute mania.