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 3
- Registration Number
- CTRI/2009/091/000643
- Lead Sponsor
- Dainippon Sumitomo Pharma America Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method