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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:
ClinicalTrials.gov Identifier:
NCT00422331
First Posted: January 15, 2007
Last Update Posted: August 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
JDS Pharmaceuticals
  Purpose
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 Intervention Phase
Bipolar Disorder Mania Drug: Lithium Carbonate Capsule Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by JDS Pharmaceuticals:

Primary Outcome Measures:
  • change from baseline in YMRS score

Secondary Outcome Measures:
  • change from baseline in CGI-BP score
  • change from baseline in MADRS score

Estimated Enrollment: 206
Study Start Date: January 2007
Estimated Study Completion Date: December 2007
  Eligibility

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
Criteria

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
  Contacts and Locations
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


Locations
United States, New York
JDS Pharmaceuticals
New York, New York, United States, 10174
Sponsors and Collaborators
JDS Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00422331     History of Changes
Other Study ID Numbers: JDS04004
Lithium TEAM-1 Study
First Submitted: January 11, 2007
First Posted: January 15, 2007
Last Update Posted: August 14, 2007
Last Verified: August 2007

Keywords provided by JDS Pharmaceuticals:
Bipolar I Disorder
Bipolar Disorder
Lithium

Additional relevant MeSH terms:
Disease
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