This is an Open-label, Multi-center, Extension Study Designed to Evaluate

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar I Disorder

Clinical Trial Details

NCT number	NCT01575561
Study type	Interventional
Source	Sunovion
Contact
Status	Completed
Phase	Phase 3
Start date	June 2012
Completion date	July 2015

View Details

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