Conditions: Bipolar I Disorder
Keywords: Lurasidone Latuda Bipolar Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 377
Healthy volunteers: no

Brief summary:
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Detailed description:
To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Arms:
arm 1: Lurasidone 20, 40, 60,80 mg flexible dose

Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 20-80 mg taken orally once daily

Protocol document: