Objective: This study evaluated the efficacy and safety of olanzapine(OLA)for the treatment of acute mania in adolescents with bipolar disorder. Methods: In this 3-week randomized, double-blind trial, pats. 13–17 years of age with a manic or mixed episode received either OLA (2.5–20mg/day; N=107) or placebo (N=54). The primary efficacy analysis was mean change from baseline-to-endpoint in Young Mania Rating Scale (YMRS) total score. Results: Signif. greater reductions in YMRS total score were observed for OLA vs. plac. (-17.7 vs. -10.0, p<.001; ES, 0.84). OLA treatment was associated with higher rates of response and remission (44.8% vs. 18.5%; p=.002, and 35.2% vs. 11.1%; p=.001) and shorter times to reach those criteria (p=.003 and p=.002) vs. plac. Somnolence, sedation, increased appetite, weight gain were treatment-emergent adverse events reported signif. more frequently among the OLA treatment group. The incidence of treatment-emergent weight gain ≥7% (41.9% vs. 1.9%; p<.001), and hyperprolactinemia were signif. greater for OLA relative to placebo. The incidence of treatment-emergent abnormal levels of glucose, cholesterol, triglycerides, or uric acid did not differ signif. between treatment groups. Other safety information including lab values and vital signs will be presented. Conclusions: Olanzapine was effective in the treatment of adolescents with bipolar mania. The types of adverse events appeared to be similar to those in adults, but may have differed in magnitude.
This study was supported by Eli Lilly & Co., Indianapolis, IN, USA
