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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 11, 2007
Last Updated: August 13, 2007
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

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

ClinicalTrials.gov processed this record on December 07, 2016