A naturalistic study of the effectiveness of oral risperidone (RIS) for the treatment of acute mania (RIS-BIM-0001)

Objectives: To investigate the effectivness of oral risperidone (RIS) on clinical symptoms in patients with acute manic or mixed episodes of bipolar disorder under naturalistic treatment conditions. Methods: Prospective, observational study. Data were documented at baseline, after 4 and 12 weeks of treatment with flexible doses of RIS. Treatment decision was at the discretion of the treating physician. Effectiveness was evaluated using YMRS, BPRS-short version, CGI-BP. Results: 440 patients (ITT, mean age 45.4(±14) years; 48% male) were documented. 89% completed the full observation period. Mean dose of RIS at endpoint was 3.6(±1.8)mg/day (with 38% on monotherapy). Total YMRS scores improved significantly from 26(±10) at baseline to 7(±7) at endpoint (p<0.0001). 82% showed an YMRS improvement of >50%. Improvements in BPRS total scores as well as in the 3 items (depression, mania and bipolar disorder) of the CGI-BP were significant (p<0.0001 for all). Overall, 86% of the physicians and 80% of patients judged the effectiveness of RIS as “good“ or “very good“ and 95% and 85%, respectively the tolerability. 10% (n=44) had at least one AE, of these 57% judged to be at least possibly related to RIS by the treating physician. Two serious AE related to underlying disease were documented (depression; condition aggravated). Conclusion: This large observational study adds further support that oral RIS in patients with acute mania is effective and well tolerated in clinical practice.

This study was supported by Janssen-Cilag GmbH, Neuss