Risperidone versus haloperidol in treatment of acute manic episodes of bipolar I disorder: a randomized double-blind controlled multicenter study

Objective To evaluate the efficacy and safety of risperidone and haloperidol in treating patients with Diagnostic and Statistical Manual of Mental Disorders-Ⅳ bipolar Ⅰ disorder acute manic episodes.Methods A randomized, double-blind, controlled multicenter clinical trial was conducted. All 173 patients received 4 weeks treatment with either risperidone (n=85, averaged dosage of 4.6 mg/d) or haloperidol (n=88, 8.0 mg/d). The main efficacy measure was the change in total score of the Young Mania Rating Scale.Results The clinical response rates were 79% in risperidone and 76% in haloperidol. There were significantly higher rates of extrapyramidal symptoms in haloperidol group (58%) than that in risperidone group (44%).Conclusion The results show that risperidone has similar therapeutic effect to haloperidol in treatment of acute manic episodes, but risperidone has better tolerability.