This trial is active, not recruiting.

Condition bipolar disorder
Treatment aripiprazole
Sponsor Cambridge Health Alliance
Collaborator Bristol-Myers Squibb
Start date April 2004
End date March 2007
Trial size 20 participants
Trial identifier NCT00226317, CHA-IRB-0030/01/04


A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Depression state
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: - DSM-IV diagnosis of bipolar disorder, any subtype; MADRS >16; MRS < 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control Exclusion Criteria: - Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations

Additional Information

Official title Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression
Principal investigator Robert T Dunn, MD, PhD
Description Study is 6 weeks long with 7 clinical visits.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Cambridge Health Alliance.