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A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study To Evaluate The Efficacy And Safety Of Lurasidone In Children And Adolescent Subjects With Bipolar I Depression
To evaluate the efficacy of lurasidone (20 - 80 mg/day flexibly dosed) compared with placebo in children and adolescent subjects with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course, and without psychotic features (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. [DSM-V] criteria) as measured by the change from Baseline in the Children's Depression Rating Scale, Revised (CDRS-R) total score.
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