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Safety and Efficacy Study of Lithium in Bipolar Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by JDS Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
JDS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00422331
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 ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
206
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00422331
JDS04004
Lithium TEAM-1 Study
Not Provided
Not Provided
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