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

Sponsor:

Information provided by:

JDS Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00422331

First received: January 11, 2007

Last updated: August 13, 2007

Last verified: August 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	January 11, 2007
Last Updated Date	August 13, 2007
Start Date ^ICMJE	January 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: January 12, 2007)	change from baseline in YMRS score
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00422331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 12, 2007)	change from baseline in CGI-BP score change from baseline in MADRS score
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Lithium in Bipolar Disorder
Official Title ^ICMJE	Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorder Mania
Intervention ^ICMJE	Drug: Lithium Carbonate Capsule
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	206
Estimated Completion Date	December 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00422331
Other Study ID Numbers ^ICMJE	JDS04004, Lithium TEAM-1 Study
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	JDS Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	JDS Pharmaceuticals
Verification Date	August 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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