Asenapine in the Treatment of Older Adults With Bipolar Disorder

University Hospitals (UH)

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Asenapine

Study type

Interventional

Funder types

Other

Identifiers

NCT01460290

39358

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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