Conditions: Bipolar I Disorder
Keywords: Lurasidone Latuda Bipolar I
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 965
Healthy volunteers: no

Brief summary:
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Detailed description:
This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter intervention 2: 20-80 mg flexible dose

Protocol document: