Status:
COMPLETED
Asenapine in the Treatment of Older Adults With Bipolar Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Bipolar Disorder
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general ...
Eligibility Criteria
Inclusion
- Subjects must have type I Bipolar disorder by DSM-IV criteria confirmed on the Mini Neuropsychiatric Interview (MINI)
- Subjects must be age 60 or older
- Subjects must have sub-optimal response to current psychotropic management including at least one of the following:
- Behaviors and symptoms of irritability, agitation, mood lability 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 BD
Exclusion
- History of intolerance or resistance to asenapine
- Clinical diagnosis of dementia or Mini-mental state (MMSE) \< 24
- History of TIA, stroke or MI within the past 12 months
- Medical illness that is the clear, underlying etiology of BD
- Unstable medical illness or condition including prolonged QT interval, which in the opinion of the study investigators, is likely to affect the outcome of the study or the subject's safety
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months.
- Rapid cycling BD defined as 4 or more discrete mood episodes within the previous 12 months.
- At high risk for self-harm or suicide
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01460290
Start Date
October 1 2011
End Date
March 1 2014
Last Update
December 30 2014
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106