Safety and Efficacy Study of Lithium in Bipolar Disorder
Information source: JDS Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Mania
Intervention: Lithium Carbonate Capsule (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: JDS Pharmaceuticals
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.
Clinical Details
Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: change from baseline in YMRS score
Secondary outcome: change from baseline in CGI-BP scorechange from baseline in MADRS score
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
JDS Pharmaceuticals, New York, New York 10174, United States
Additional Information
Starting date: January 2007
Ending date: December 2007
Last updated: August 13, 2007
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