Safety and Efficacy Study of Lithium in Bipolar Disorder

Phase 3

• Conditions: Bipolar Disorder; Mania

• Registration Number: NCT00422331
• Lead Sponsor: JDS Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-13
• Last Update Posted: 2007-08-14
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline in YMRS score

Secondary Outcome Measures

Name	Time	Method
change from baseline in CGI-BP score
change from baseline in MADRS score

Trial Locations

Locations (1)

JDS Pharmaceuticals; 🇺🇸 New York, New York, United States