Risperidone Combination in the Acute Treatment of Bipolar Mania and Mixed Episode: Prospective, Multicenter, Open Trial / 대한정신약물학회지

ABSTRACT

OBJECTIVE: Although mood stabilizer monotherapy is the recommended initial therapy for bipolar disorder, the use of atypical antipsychotics in bipolar patients is increasing recently. Moreover, the medical literature is demonstrating that the combination of atypical antipsychotics and mood stabilizers is a more effective therapy. The goal of this study was to assess the efficacy of risperidone in patients with acute manic and mixed state of bipolar disorder. METHODS: This study was a 4-week, open-label, combination, prospective investigation using risperidone in combination with mood stabilizers. In total, 114 patients with a DSM-IV diagnosis of bipolar disorder, manic or mixed episode, were recruited. Risperidone was given in combination with mood stabilizers in doses according to clinical response and tolerability. Efficacy was assessed with the Young Mania Rating Scale (YMRS), the Hamilton Rating Scale for Depression (HAMD), the Brief Psychiatric Rating Scale (BPRS), Global Assessment Scale (GAS), and the Clinical Global Impressions Scale-Bipolar (CGI-BP). The Simpson-Angus Rating Scale (SARS) was applied to assess extrapyramidal symptoms. RESULTS: The combination of risperidone with mood stabilizers produced highly significant improvements (p<0.001) on the YMRS, HAMD, BPRS, GAS, and CGI-BP at both 1 week and 4 weekweeks. Analysis of the YMRS, BPRS, GAS, and CGI-BP scores revealed significant improvement in both the manic and mixed group. The HAMD score was decreased only in the mixed group. Body weight was increased significantly after 1 week. Risperidone was well tolerated, and adverse events were mostly mild, with the most frequent extrapyramidal symptoms and sedation. CONCLUSION: Our findings suggest that the combination of risperidone with mood stabilizers was an effective and safe treatment for acute manic symptoms and coexisting depressive symptoms of bipolar disorder. Randomized, double-blind, placebo or active controlled studies are needed.