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Safety and Efficacy Study of Lithium in Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by JDS Pharmaceuticals.
Recruitment status was  Active, not recruiting
Information provided by:
JDS Pharmaceuticals Identifier:
First received: January 11, 2007
Last updated: August 13, 2007
Last verified: August 2007

January 11, 2007
August 13, 2007
January 2007
Not Provided
change from baseline in YMRS score
Same as current
Complete list of historical versions of study NCT00422331 on Archive Site
  • change from baseline in CGI-BP score
  • change from baseline in MADRS score
Same as current
Not Provided
Not Provided
Safety and Efficacy Study of Lithium in Bipolar Disorder
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder

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.

Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bipolar Disorder
  • Mania
Drug: Lithium Carbonate Capsule
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2007
Not Provided

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
JDS04004, Lithium TEAM-1 Study
Not Provided
Not Provided
JDS Pharmaceuticals
Not Provided
Not Provided
JDS Pharmaceuticals
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP