Overview

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