Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol

In a randomized, double-blind trial, patients with acute bipolar mania received 1–6 mg/day of risperidone, 2–12 mg/day of haloperidol, or placebo for 3 weeks, followed by double-blind risperidone or haloperidol for 9 weeks. Of 438 patients, 154 were randomized to risperidone, 144 to haloperidol, and 140 to placebo. The mean±S.D. modal doses were 4.2±1.7 mg/day of risperidone and 8.0±3.6 mg/day of haloperidol during the initial 3-week phase and 4.1±1.8 and 7.4±3.7 mg/day during the 12-week period. At week 3, mean Young Mania Rating Scale (YMRS) score reductions from baseline were significantly greater in patients receiving risperidone than placebo ( p