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Safety and Efficacy Study of Lithium in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00422331
Recruitment Status : Unknown
Verified August 2007 by JDS Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2007
Last Update Posted : August 14, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mania Drug: Lithium Carbonate Capsule Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Study Start Date : January 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Primary Outcome Measures :
  1. change from baseline in YMRS score

Secondary Outcome Measures :
  1. change from baseline in CGI-BP score
  2. change from baseline in MADRS score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422331

United States, New York
JDS Pharmaceuticals
New York, New York, United States, 10174
Sponsors and Collaborators
JDS Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00422331     History of Changes
Other Study ID Numbers: JDS04004
Lithium TEAM-1 Study
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: August 14, 2007
Last Verified: August 2007

Keywords provided by JDS Pharmaceuticals:
Bipolar I Disorder
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs