Status:
COMPLETED
Aripiprazole in the Treatment of Bipolar Depression
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.
Detailed Description
Study is 6 weeks long with 7 clinical visits.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00226317
Start Date
April 1 2004
End Date
February 1 2008
Last Update
April 18 2017
Active Locations (1)
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1
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139