An open-label trial of risperidone in children and adolescents with bipolar disorder.

Objective: The aim of this study was to evaluate the potential of risperidone as a treatment of pediatric bipolar disorder.

Methods: This was an 8-week, open-label, prospective study of risperidone monotherapy (1.25 +/- 1.5 mg/d) for 30 bipolar youths (manic, mixed, or hypomanic; 6-17 years of age).

Results: Twenty-two of the 30 youths (73%) completed the study. Using predefined criteria for improvement (a Clinical Global Impressions Improvement in Mania score of < or =2 at endpoint), the response rate for manic symptoms was 70%. The significant reduction in symptoms of mania resulted in a mean Young Mania Rating Scale (YMRS) score 13.5 at endpoint, indicating mild residual symptoms. Weight increased significantly from baseline (2.1 +/- 2.0 kg; p < 0.001) and there was a four-fold increase in prolactin levels from baseline (p < 0.001).

Conclusions: Open-label risperidone treatment was associated with a significant shortterm improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are needed to confirm these preliminary results.