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

First Received on January 11, 2007. Last Updated on August 13, 2007 History of Changes

Sponsor:	JDS Pharmaceuticals
Information provided by:	JDS Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00422331

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 III

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:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

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

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
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium Carbonate
Lithium
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 09, 2012