Safety and Efficacy Study of Lithium in Bipolar Disorder
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Lead SponsorJDS Pharmaceuticals
Indication/ConditionBipolar Disorder Mania [, ]
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.
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