Overview

This trial is active, not recruiting.

Condition bipolar disorder
Treatment asenapine
Phase phase 4
Sponsor University Hospitals of Cleveland
Collaborator Case Western Reserve University
Start date October 2011
End date June 2014
Trial size 30 participants
Trial identifier NCT01460290, 39358

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
12-weeks of open-label asenapine treatment
asenapine Saphris
Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.

Primary Outcomes

Measure
Change in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D)
time frame: Baseline and 12 weeks
Change in manic symptoms as measured by the Young Mania Rating Scale (YMRS)
time frame: 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)
time frame: Baseline and 12 weeks
Change in perception of physical health as measured by the Short Form General Health Survey (SF-12)
time frame: Baseline and 12 weeks
Change in perception of mental health as measured by the Short Form General Health Survey (SF-12)
time frame: Baseline and 12 weeks
Change in depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
time frame: Baseline and 12 weeks
Change in bipolar disorder symptoms as measured by the Brief Psychiatric Rating Scale (BPRS)
time frame: Baseline and 12 weeks
Change in cognitive status as measured by the Stroop Task
time frame: Baseline and 12 weeks
Change in cognitive status as measured by the Trail Making Test
time frame: Baseline and 12 weeks
Change in cognitive status as measured by the Hopkins Verbal Learning Test (HVLT)
time frame: Baseline and 12 weeks
Change in cognitive status as measured by the Dementia Rating Scale (DRS)
time frame: Baseline and 12 weeks
World Health Organization Disability Assessment Scale (WHO-DAS)
time frame: 12 weeks
Barnes drug-induced Akathisia Rating Scale (BARS)
time frame: Baseline and 12 weeks
Assessment of motor control abnormality as measured by the Simpson Angus Scale (SAS)
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Asenapine in the Treatment of Older Adults With Bipolar Disorder
Principal investigator Martha Sajatovic, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University Hospitals of Cleveland.