A post-marketing surveillance study of risperidone as adjunctive therapy to mood stabilizers in the treatment of manic phase bipolar I disorder

ABSTRACT

Objectives: The purpose of this study was to assess symptom improvement with, and safety (measured as tolerability) of, risperidone as adjunctive therapy to mood stabilizers in the treatment of bipolar I disorder, manic phase. Methods: Eight hundred sixty seven Filipino patients, recruited from 46 centers across the Philippines and diagnosed according to DSM-IV criteria as having bipolar disorder, current phase manic, completed an 8-week open trial of risperidone as add-on therapy to mood stabilizers. Doses of risperidone were started at 0.5 - 2 mg per day for the first 2 days, and escalated or reduced based on clinical judgment on succeeding days. Treatment was evaluated 1, 2, 4 and 8 weeks after baseline assessment. The Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HAM-D), Clinical Global Impression Scale for Severity (CGI-S) and Clinical Global Impression Scale for Improvement (CGI-I) were used to measure symptom reduction with risperidone use, while the Extrapyramidal Symptoms Rating Scale and incidence of adverse events were employed to determine drug safety. Results: Results showed significant reduction in manic and depressive symptoms throughout the study as measured by statistically significant decreases in mean YMRS and HAM-D scores. CGI scores likewise showed significant improvement from baseline to study end with an increasing percentage of patients who showed steady improvement throughout the trial. There was a low incidence of extrapyramidal symptoms (EPS), majority of which were mild. Only 2 other non-EPS adverse events occurred in the study. Conclusion: This study demonstrated reductions in manic and depressive symptoms with risperidone use and showed that risperidone was safe as adjunct therapy to mood stabilizers for the treatment of manic phase bipolar disorder.