Status:
UNKNOWN
Safety and Efficacy Study of Lithium in Bipolar Disorder
Lead Sponsor:
JDS Pharmaceuticals
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Diagnosis of Bipolar 1 Disorder;
- Hospitalized or in the process of being hospitalized for a manic or mixed episode
Exclusion
- History of rapid cycling;
- History of hypersensitivity or adverse reaction to lithium
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00422331
Start Date
January 1 2007
End Date
December 1 2007
Last Update
August 14 2007
Active Locations (1)
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1
JDS Pharmaceuticals
New York, New York, United States, 10174