Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
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

No publications provided

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:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Lithium
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014