Asenapine in the Treatment of Older Adults With Bipolar Disorder

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Case Western Reserve University
• Treatments: Asenapine

Criteria

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