Safety and Efficacy Study of Lithium in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00422331
• Other study ID #: JDS04004
• Secondary ID: Lithium TEAM-1 S
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 11, 2007
• Last updated: August 13, 2007
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2007
• Source: JDS Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mania

Intervention

Drug:
• Lithium Carbonate Capsule

Locations

Country	Name	City	State
United States	JDS Pharmaceuticals	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
JDS Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in YMRS score
Secondary	change from baseline in CGI-BP score
Secondary	change from baseline in MADRS score