Background: These analyses compared efficacy of olanzapine in patients with bipolar mania with or without mixed features, as defined in the DSM-5.
Methods: Pooled data from 3 placebo-controlled olanzapine studies in patients having bipolar I disorder with manic/mixed episode were analyzed ( N =228 olanzapine; N =219 placebo). Patients were categorized for mixed features by number of concurrent depressive symptoms at baseline (0, 1, and 2 [category A; without mixed features], and ≥3 [category B; with mixed features]), as determined by HAM-D 17 item score ≥1. Depressive symptoms corresponded to 6 HAM-D 17 items in the DSM-5 definition of manic episode with mixed features. Primary efficacy was evaluated by changes in the baseline-to-3-week YMRS total score. Results: Patients were categorized into A ( N =322; 72.0%) or B ( N =125; 28.0%). Mean baseline YMRS total scores were 28.1 in category A and 27.8 in category B…… […]