BACKGROUND: The aim of this study was to assess the effectiveness and safety of risperidone monotherapy for acute and continuation treatment of mania. METHOD: Ninety-six DSM-IV acutely manic bipolar patients with a Young mania rating score (YMRS) of 20 or more entered this open, multicentre, 6-month study. Efficacy was assessed with the YMRS, the positive and negative syndrome scale (PANSS) and the clinical global impressions scale (CGI). Safety was assessed with the UKU side effect rating scale and with the Hamilton depression rating scale, for the assessment of a switch to depression. RESULTS: 80 patients (83.3%) completed the study. Using the last-observation-carried-forward analysis, risperidone produced highly significant improvements (p<0.0001) on the all efficacy measures from weeks 1 (YMRS) and 4 (PANSS and CGI) onwards, for a 6-month period. There was a significant increase in extrapyramidal side-effects by week 4 (p=0.015) and a significant decrease at the 6-month endpoint (p=0.027). Risperidone did not induce depressive symptoms, as mean HDRS scores actually improved (p<0.0001), and exacerbation of mania was rare (n=4, 4.2%). The mean dose of risperidone was 4.2 mg/day. CONCLUSION: Monotherapy with risperidone is effective and well tolerated in acute and continuation treatment of mania. The results should be confirmed in randomized, double-blind clinical trials. Copyright 2004 John Wiley & Sons, Ltd.
RCT Entities:
BACKGROUND: The aim of this study was to assess the effectiveness and safety of risperidone monotherapy for acute and continuation treatment of mania. METHOD: Ninety-six DSM-IV acutely manic bipolarpatients with a Young mania rating score (YMRS) of 20 or more entered this open, multicentre, 6-month study. Efficacy was assessed with the YMRS, the positive and negative syndrome scale (PANSS) and the clinical global impressions scale (CGI). Safety was assessed with the UKU side effect rating scale and with the Hamilton depression rating scale, for the assessment of a switch to depression. RESULTS: 80 patients (83.3%) completed the study. Using the last-observation-carried-forward analysis, risperidone produced highly significant improvements (p<0.0001) on the all efficacy measures from weeks 1 (YMRS) and 4 (PANSS and CGI) onwards, for a 6-month period. There was a significant increase in extrapyramidal side-effects by week 4 (p=0.015) and a significant decrease at the 6-month endpoint (p=0.027). Risperidone did not induce depressive symptoms, as mean HDRS scores actually improved (p<0.0001), and exacerbation of mania was rare (n=4, 4.2%). The mean dose of risperidone was 4.2 mg/day. CONCLUSION: Monotherapy with risperidone is effective and well tolerated in acute and continuation treatment of mania. The results should be confirmed in randomized, double-blind clinical trials. Copyright 2004 John Wiley & Sons, Ltd.