RESUMO
OBJECTIVE: The primary purpose of this study was a replication of the effectiveness and tolerability of risperidone in the treatment of patients with acute mania in very larger cohort in naturalistic treatment setting to extend the data on the effect and tolerability of risperidone in the treatment of patients with acute mania to Asian population. METHODS: A total of 909 patients with DSM-IV criteria of bipolar disorder current manic and hypomanic episode, entered this large, open, multicentre study. The Young Mania Rating Scale (YMRS), Clinical Global Impression (CGI) and Simpson-Angus Rating Scale (SARS) were measured at baseline and weeks 1, 3 and 6, for the assessment of effectiveness and extrapyramidal symptom (EPS). RESULTS: This study showed statistically significant reduction of scores on the YMRS and CGI-s (mean change=-23.5+/-11.8, p<0.0001;mean change=-2.7+/-1.5, p<0.0001, respectively) from the baseline to the endpoint (week 6). Number of patients with 50% reduction or more in the YMRS and CGI-s scores was 693 (77.8%) and 630 (70.7%) at endpoint, respectively. There were no statistically significant increments of scores on SARS. Risperidone was generally well tolerated. CONCLUSION: The present larger open study demonstrates that risperidone add-on therapy is effective and tolerable in treatment of bipolar disorder, replicating results in various controlled and uncontrolled studies from Western countries.