A prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder

Objective: The goal of this study was to assess the effectiveness and toler ability of olanzapine in the treatment of acute mania in children and adole scents. Methods: This was an 8-week, open-label, prospective study of olanzapine mo notherapy (dose range 2.5-20 mg/day) involving 23 bipolar youths (manic, mi xed, or hypomanic; 5-14 years old). Weekly assessments were made using the Young Mania Rating Scale (YMRS), Clinical Global Impressions Severity Scale (CGI-S), Brief Psychiatric Rating Scale, and Children's Depression Rating Scale. Adverse events were assessed through self-reports, vital sign and we ight monitoring, laboratory analytes, and extrapyramidal symptom rating sca les (Barnes Akathisia Scale, Simpson-Angus Scale, and Abnormal Involuntary Movement Scale). Results: Twenty-two of the 23 youths (96%) completed the study. Olanzapine treatment was associated with significant improvement in mean YMRS score (- 19.0 +/- 9.2, p < 0.001). Using predefined criteria for improvement of grea ter than or equal to 30% decline in the YMRS and a CGI-S Mania score of les s than or equal to3 at endpoint, the overall response rate was 61%. Overall , olanzapine was well tolerated, and extrapyramidal symptom measures were n ot significantly different from baseline. Body weight increased significant ly over the study (5.0 +/- 2.3 kg, p < 0.001). Conclusions: Open-label olanzapine treatment was efficacious and well toler ated in the treatment of acute mania in youths with bipolar disorder. Futur e placebo-controlled, double-blind studies are warranted.