NCT00422331
Unknown
Phase 3
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
JDS Pharmaceuticals1 site in 1 country206 target enrollmentJanuary 2007
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- JDS Pharmaceuticals
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- change from baseline in YMRS score
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Bipolar 1 Disorder;
- •Hospitalized or in the process of being hospitalized for a manic or mixed episode
Exclusion Criteria
- •History of rapid cycling;
- •History of hypersensitivity or adverse reaction to lithium
Outcomes
Primary Outcomes
change from baseline in YMRS score
Secondary Outcomes
- change from baseline in CGI-BP score
- change from baseline in MADRS score
Study Sites (1)
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