Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride

Criteria

Inclusion Criteria:

• Subject is diagnosed with bipolar I disorder, most resent episode depressed

• Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

• History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode

• Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization

• Imminent risk of suicide or injury to self, others, or property