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<0.001). Differences between
risperidone and
haloperidol on this efficacy measure were not significant. Further reductions in YMRS scores were seen in patients receiving
risperidone or
haloperidol during the subsequent 9 weeks. No unexpected adverse events were reported.
Extrapyramidal disorder and hyperkinesias, the most commonly reported adverse events with
antipsychotic use, occurred less frequently with
risperidone than
haloperidol. We conclude that
risperidone monotherapy was an effective and well-tolerated treatment for bipolar
mania and that efficacy was maintained over the long term.