Phase 4
Completed N=15
Asenapine in the Treatment of Older Adults With Bipolar Disorder
Source: ClinicalTrials.gov NCT01460290 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Aug 2014
Primary outcomePrimary: Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) — 17.5; 10.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) |
17.5; 10.3 | — |
| PRIMARY Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) |
27.9; 18.1 | — |
| SECONDARY Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) |
4.4; 2.2; 2.7; 1.9; 3.6; 1.7 | — |
| SECONDARY Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) |
46.8; 46.4 | — |
| SECONDARY Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) |
38.7; 43.1 | — |
| SECONDARY Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) |
27.9; 18.1 | — |
| SECONDARY Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) |
35.1; 28.6 | — |
| SECONDARY Change in Cognitive Status as Measured by the Stroop Task |
75.7; 75.9; 53.6; 58.6; 30.3; 30.6 | — |
| SECONDARY Change in Cognitive Status as Measured by the Trail Making Test |
57.7; 47.3; 189.0; 126.3 | — |
| SECONDARY Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) |
8.6; 9.6 | — |
| SECONDARY Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS) |
131.2; 135.6 | — |
| SECONDARY World Health Organization Disability Assessment Scale (WHO-DAS) |
4.3; 4.7; 2.6; 2.4; 9.1; 7.1 | — |
| SECONDARY Barnes Drug-induced Akathisia Rating Scale (BARS) |
0.0; 0.1 | — |
| SECONDARY Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS) |
0.4; 0.5 | — |
| SECONDARY Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) |
8.6; 9.6 | — |
| SECONDARY Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) |
8.6; 9.6 | — |
| SECONDARY Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) |
8.6; 9.6 | — |
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:
- Behaviors and symptoms of irritability, agitation, mood lability or diminished ability to interact with others in their place of residence
- 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
Data sourced from ClinicalTrials.gov (NCT01460290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.