Background: Risperidone, a 5-HT2 and D2 antagonist, has been shown to be an effective antipsychotic in the treatment of schizophrenia but has unclear efficacy in the treatment of psychotic affective disorders. The purpose of the study was to assess the efficacy of risperidone in the treatment of acute mania with psychotic features.
Method: We conducted an open-label pilot study of risperidone and concurrent mood-stabilizing drugs in the treatment of acute mania with psychotic features. Patients were diagnosed with the Structured Clinical Interview for DSM-III-R (SCID). Efficacy was measured weekly with the use of the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS).
Results: Ten women and 5 men (mean age = 38 years) were included in the study. Of the 13 patients who completed 2 weeks of treatment, 8 of these 13 had a 50% improvement of the BPRS, and all 13 had at least a 25% improvement (p = .002, 95% confidence interval [CI] = 46.0 to 57.8). Of the 8 patients who completed 6 weeks of treatment, 7 of the 8 had a 50% improvement, and all 8 had a 25% improvement (p = .012, 95% CI = 52.4 to 69.3). Similar results were obtained with the YMRS. By the second week of treatment, 10 of the 13 patients remaining in treatment had at least a 50% improvement, and 12 of these 13 had a 25% improvement (p = .002, 95% CI = 55.1 to 89.9). By the sixth week, all of the 8 patients remaining in treatment had a 75% improvement (p = .012, 95% CI = 90.5 to 102.8). The medication was well tolerated, and no case worsened.
Conclusion: When used with concomitant mood-stabilizing drugs, risperidone may be effective and well tolerated in patients with acute mania with psychotic features. Considering the open design, small sample size, and limited period of observation, further studies need to be conducted.