Overview

Aripiprazole in Late Life Bipolar Disorder

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
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-depressive illness).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborator:
Bristol-Myers Squibb
Treatments:
Aripiprazole
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.