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Safety and Efficacy Study of Lithium in Bipolar Disorder

Information source: JDS Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Mania

Intervention: Lithium Carbonate Capsule (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: JDS Pharmaceuticals


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.

Clinical Details

Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: change from baseline in YMRS score

Secondary outcome:

change from baseline in CGI-BP score

change from baseline in MADRS score


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

JDS Pharmaceuticals, New York, New York 10174, United States
Additional Information

Starting date: January 2007
Last updated: August 13, 2007

Page last updated: August 23, 2015

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