Sunovion Statistical Data Analysis Center for Pediatric Clinical Trials Program

PI: Chen

D1050301: Randomized, double-blind, placebo-controlled, fixed-dose regimen, multicenter, study to evaluate the efficacy and safety of lurasidone in adolescent subjects with schizophrenia. To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with acute schizophrenia (diagnosed by DSM-IV-TR criteria)

D1050302: An OpenLabel, Multicenter, Clinical Extension Study to Evaluate the Long-Term Safety and Efficacy of Lurasidone in Pediatric and Adolescent Subjects. To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study.

D1050325: Randomized, Double-blind, Placebo-controlled, Fixed-dose regimen, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Pediatric and Adolescent Subjects with Irritability Associated with Autistic Disorder. To evaluate the efficacy of lurasidone (20 mg/day and 60 mg/day) compared with placebo in pediatric and adolescent subjects with irritability (including symptoms of aggression, tantrums, rapidly changing moods, and self -injurious behavior) associated with autistic disorder

D1050326: Randomized, double-blind, placebo-controlled, flexible-dose regimen, multicenter, study to evaluate the efficacy and safety of lurasidone in adolescent subjects with bipolar 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.