Back to resultsSafety and Efficacy Study of Lithium in Bipolar Disorder
Primary Purpose
Bipolar Disorder, Mania
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lithium Carbonate Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder, Bipolar Disorder, Lithium
Eligibility 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
Sites / Locations
- JDS Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00422331
Brief Title
Safety and Efficacy Study of Lithium in Bipolar Disorder
Official Title
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
JDS Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mania
Keywords
Bipolar I Disorder, Bipolar Disorder, Lithium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate Capsule
Primary Outcome Measure Information:
Title
change from baseline in YMRS score
Secondary Outcome Measure Information:
Title
change from baseline in CGI-BP score
Title
change from baseline in MADRS score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
JDS Pharmaceuticals
City
New York
State/Province
New York
ZIP/Postal Code
10174
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Lithium in Bipolar Disorder
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