Asenapine in the Treatment of Older Adults With Bipolar Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 12/28/2013 |
| Start Date: | October 2011 |
| End Date: | December 2013 |
| Contact: | Martha Sajatovic, M.D. |
| Email: | Martha.Sajatovic@UHhospitals.org |
| Phone: | 216-844-2808 |
Objectives: The investigators propose a first-ever, prospective trial of asenapine in older
adults with BD to evaluate effects on mood symptoms, tolerability and functional/general
health status. Given the dearth of treatment data on older adults with BD, findings are
likely to be of substantial clinical interest, may inform larger future studies and will
assist in refining bipolar treatment recommendations.
Hypotheses:
Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive
symptoms in older adults with BD.
Secondary: Asenapine therapy will be associated with improved functional and general health
status, improved global psychopathology, and good tolerability in older adults with BD.
adults with BD to evaluate effects on mood symptoms, tolerability and functional/general
health status. Given the dearth of treatment data on older adults with BD, findings are
likely to be of substantial clinical interest, may inform larger future studies and will
assist in refining bipolar treatment recommendations.
Hypotheses:
Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive
symptoms in older adults with BD.
Secondary: Asenapine therapy will be associated with improved functional and general health
status, improved global psychopathology, and good tolerability in older adults with BD.
Inclusion Criteria:
- 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:
1. Behaviors and symptoms of irritability, agitation, mood lability or diminished
ability to interact with others in their place of residence
2. Diminished ability to take care of basic personal needs in their place of
residence due to symptoms of BD
Exclusion Criteria:
- 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
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