Status:
COMPLETED
Aripiprazole in Late Life Bipolar Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-...
Detailed Description
While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipol...
Eligibility Criteria
Inclusion
- Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
- Must be age 50 or older
- Must have sub-optimal response to current psychotropic management including at least one of the following:
- Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence
- Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder
- Intolerance to current psychotropic medications; and
- Must live in the Northeast Ohio area.
Exclusion
- An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
- Receiving carbamazepine.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00194038
Start Date
April 1 2004
End Date
June 1 2006
Last Update
December 17 2014
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