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

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

Summary

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

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

Details

• Lead Sponsor: Sunovion
• Treatments: Lithium Carbonate; Lurasidone Hydrochloride; Valproic Acid

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

• Subject must be taking lithium or divalproex at least 28 days prior to screening

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