Safety and Efficacy Study of Lithium in Bipolar Disorder
This trial is active, not recruiting.
|Conditions||bipolar disorder, mania|
|Treatment||lithium carbonate capsule|
|Start date||January 2007|
|End date||December 2007|
|Trial size||206 participants|
|Trial identifier||NCT00422331, JDS04004, Lithium TEAM-1 Study|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
change from baseline in YMRS score
change from baseline in CGI-BP score
change from baseline in MADRS score
Male or female participants from 18 years up to 65 years old.
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
|Official title||Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder|
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