Safety and Efficacy Study of Lithium in Bipolar Disorder
Phase 3
- Conditions
- Bipolar DisorderMania
- Registration Number
- NCT00422331
- Lead Sponsor
- JDS Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 206
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change from baseline in YMRS score
- Secondary Outcome Measures
Name Time Method change from baseline in CGI-BP score change from baseline in MADRS score
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which lithium modulates GSK-3β activity in Bipolar I Disorder treatment?
How does lithium compare to valproate in managing acute mania symptoms in Bipolar I Disorder patients?
Which biomarkers correlate with lithium response in Bipolar I Disorder during manic episodes?
What are the long-term adverse event profiles of lithium versus atypical antipsychotics in Bipolar I Disorder?
How do lithium's mood-stabilizing effects interact with other first-line treatments for Bipolar I Disorder?
Trial Locations
- Locations (1)
JDS Pharmaceuticals
🇺🇸New York, New York, United States
JDS Pharmaceuticals🇺🇸New York, New York, United States