Conditions: Bipolar I Depression
Keywords: Lurasidone, Latuda, Bipolar Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 350
Healthy volunteers: no

Brief summary:
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Detailed description:
This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of flexibly dosed lurasidone (20 - 80 mg/day) for 6 weeks compared with placebo in children and adolescent subjects with depression associated with Bipolar I Disorder (bipolar depression).

Arms:
arm 1: Luradisone 20- 80 mg administered once daily arm 2: Placebo administered once daily

Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Lurasidone flexibly dosed 20-80 mg once daily intervention 2: Placebo Comparator once daily

Protocol document: