ASPOFAFF :: Journal - Volume 2 :: Volume 2 - Issue 1 :: Vol 2 - Iss 1 - Short Communication - Rapid Antimanic effect of Risperidone: A 3-week, double-blind, placebo-controlled trial


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ASPOFAFF :: Journal - Volume 2 :: Volume 2 - Issue 1 :: Vol 2 - Iss 1 - Short Communication - Rapid Antimanic effect of Risperidone: A 3-week, double-blind, placebo-controlled trial

Vol 2 - Iss 1 - Short Communication - Rapid Antimanic effect of Risperidone: A 3-week, double-blind, placebo-controlled trial #54

Rapid Antimanic effect of Risperidone: A 3-week, double-blind, placebo-controlled trial Hirschfeld R1, Keck P2, Karcher K3, Kramer M4, Grossman F3, F Denis5 1 Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch, Galveston, Texas, USA 2 Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA; 3 Janssen Research Foundation, Titusville, New Jersey, USA; 4Johnson and Johnson Pharmaceutical Research and Development, Titusville, New Jersey, USA 5 Janssen-Cilag, Medical Affairs Psychiatry, Issy Les Moulineaux, France. Objective: To evaluate the efficacy and tolerability of flexible doses of risperidone in acute bipolar mania. Methods: For 3 weeks, 279 patients in an acute manic episode of bipolar I disorder received 1–6 mg/day of risperidone. Efficacy was measured as change from baseline to treatment endpoint in Young Mania Rating Scale (YMRS) scores. Results: The trial was completed by 56% of the 125 patients in the risperidone group, and 42% of the 134 patients in the placebo group. The mean modal dose of risperidone was 4.1 mg/day. Improvements in YMRS scores were significantly greater in the risperidone than placebo group at endpoint (–11.1 ± 0.9 vs –5.0 ± 0.9; p<0.001). Significant between-group differences in change scores were seen as early as 3 days after start of treatment (risperidone, –6.9 ± 0.6; placebo, –4.3 ± 0.5; p<0.001) and at weeks 1, 2, and 3. The most common adverse event reported by patients receiving risperidone was somnolence (28%). Conclusion: Risperidone was efficacious and well tolerated in the treatment of patients with acute bipolar mania, with a rapid onset of action seen as early as day 3.

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