Risperidone safety and efficacy in the treatment of bipolar and schizoaffective disorders: Results from a 6-month, multicenter, open study

Background: The goal of this study was to assess the efficacy and safety of risperidone in bipolar and schizoaffective disorders. Method. 541 patients entered this open, multicenter, 6-month study. Patient s were entered provided that they fulfilled DSM-IV criteria for bipolar dis order or schizo affective disorder, bipolar type, during a manic, hypomanic , mixed, or depressive episode. Risperidone was added to any previous mood- stabilizing medication that the patients were taking. Efficacy was assessed with the Young Mania Rating Scale (YMRS), the Hamilton Rating Scale for De pression (HAM-D), the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impressions scale (CGI). Extrapyramidal symptoms (EPS) wer e assessed using the UKU Side Effect Rating Scale. Results: 430 patients completed the study. Addition of risperidone produced highly significant improvements (p < .0001) on the YMRS and HAM-D at both 6 weeks and 6 months and on the CGI and the scales of the PANSS at both 4 w eeks and 6 months. There was a significant reduction in UKU total and subsc ale scores at 6 months. The mean dose of risperidone was 3.9 mg/day. There was no single case of new-emergent tardive dyskinesia, and there was a very low incidence of exacerbation of mania within the first 6 weeks (2%). Adve rse events were few and mostly mild, the most frequent being EPS and weight gain. Conclusion: This large study provides additional evidence that risperidone is effective and well tolerated when combined with mood stabilizers in the treatment of bipolar disorder and schizoaffective disorder, bipolar type. P revious concerns about exacerbation of manic symptoms were not confirmed.