Risperidone has shown to be effective and generally well tolerated in the treatment of patients with acute manic episodes in bipolar disorder when given as monotherapy or in combination in randomized-controlled-trials. This non-interventional study served to add evidence for therapeutic benefit of risperidone in this indication in a clinical routine-setting.

Prospective, multi-center non-interventional trial (RIS-BIM-4001) performed in Germany. Inpatients with a baseline score ≥20 in the Young-Mania-Rating-Scale (YMRS) were eligible for enrollment. All patients were evaluated based on intent-to-treat-analysis (ITT).

251 patients were evaluated (54% female, median age 46 years). The most frequent concomitant medications during the study were valproic acid (40%), lorazepam (36%), diazepam (33%) and lithium (24%). The mean daily dose of risperidone at endpoint was 4.5±1.5mg/day. Mean YMRS total score improved significantly from baseline to endpoint (33.6±8.5 to 14.6±8.8; p<0.0001), also mean MADRS total score (13.14±5.83 to 7.18±5.8; p<0.0001) and mean BPRS total score (13.5±5.1 to 7.4±3.6; p<0.0001). A total of 185 AEs was documented in 100 (39.84% out of the total ITT-patients), thereof 102 AEs (55,1%) in 59 patients (23.51%) were evaluated by the physicians an at least possible causal relationship to risperidone. Most frequent were EPS (6.4%).

In this non-interventional trial oral risperidone treatment was associated with a significant and clinically relevant improvement of psychopathology. These data are in line with the results of previous randomized controlled trials and support the good tolerability and safety of risperidone in the treatment of bipolar inpatients with acute moderate to severe manic symptoms.