Clinical trial NCT01460290: Asenapine in the Treatment of Older Adults With Bipolar Disorder
Official title: Asenapine in the Treatment of Older Adults With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2011-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline and 12 weeks
measure: Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)
timeFrame: Baseline and 12 weeks
measure: Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)
timeFrame: Baseline and 12 weeks
measure: Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)
timeFrame: Baseline and 12 weeks
measure: Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and 12 weeks
measure: Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Stroop Task
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Trail Making Test
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)
timeFrame: Baseline and 12 weeks
measure: World Health Organization Disability Assessment Scale (WHO-DAS)
timeFrame: 12 weeks
measure: Barnes Drug-induced Akathisia Rating Scale (BARS)
timeFrame: Baseline and 12 weeks
measure: Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References: