Background: The purpose of this analysis was to assess rates of symptomatic remission in patients with bipolar mania receiving risperidone in a double-blind, parallel-group, multicenter, placebo-controlled trial conducted in India.
Method: Two hundred ninety-one adult patients who met DSM-IV criteria for bipolar I disorder manic or mixed episode were randomly assigned to flexible doses of risperidone (1-6 mg/day, N = 146) or placebo (N = 145) for up to 3 weeks. An entry Young Mania Rating Scale (YMRS) score of >or= 20 was required at trial screening and baseline. Remission was defined as achieving and maintaining a YMRS score <or= 8 for the remainder of the trial or until censor. Time to first onset of remission was assessed using Cox proportional hazards model. Presence or absence of remission was analyzed using logistic regression. Data were collected from March 2001 to December 2001.
Results: Of the 291 patients randomly assigned to treatment, 290 received at least 1 postbaseline assessment and were included in the analysis. The patients' mean YMRS score at baseline was 37.2 +/- 7.9. Remission was achieved by 42% of patients in the risperidone group and 13% of patients in the placebo group. After adjusting for psychosis, baseline YMRS score, sex, number of mood cycles in the previous year, and treatment, the odds of remission for patients receiving risperidone was 5.6 (95% CI = 3.0 to 10.4; chi(2) = 29.9, p < .0001). Similarly, the adjusted hazard of remission for the risperidone patients was 4.0 (95% CI = 2.3 to 6.8; chi(2) = 25.9, p < .0001).
Conclusion: A significant proportion of acutely manic patients receiving risperidone monotherapy achieved symptomatic remission within 3 weeks.