This trial is active, not recruiting.

Conditions bipolar disorder, mania
Treatment lithium carbonate capsule
Phase phase 3
Sponsor JDS Pharmaceuticals
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

change from baseline in YMRS score
time frame:

Secondary Outcomes

change from baseline in CGI-BP score
time frame:
change from baseline in MADRS score
time frame:

Eligibility Criteria

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

Additional Information

Official title Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Trial information was received from ClinicalTrials.gov and was last updated in August 2007.
Information provided to ClinicalTrials.gov by JDS Pharmaceuticals.