Asenapine in the Treatment of Older Adults With Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Asenapine
12-weeks of open-label asenapine treatment
干预措施: Asenapine (Drug)
结局指标
主要结局
Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)
时间窗: Baseline and 12 weeks
The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.
Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)
时间窗: Baseline and 12 weeks
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
次要结局
- Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)(Baseline and 12 weeks)
- Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)(Baseline and 12 weeks)
- Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)(Baseline and 12 weeks)
- Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)(Baseline and 12 weeks)
- Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)(Baseline and 12 weeks)
- Change in Cognitive Status as Measured by the Stroop Task(Baseline and 12 weeks)
- Change in Cognitive Status as Measured by the Trail Making Test(Baseline and 12 weeks)
- Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)(Baseline and 12 weeks)
- Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)(Baseline and 12 weeks)
- World Health Organization Disability Assessment Scale (WHO-DAS)(12 weeks)
- Barnes Drug-induced Akathisia Rating Scale (BARS)(Baseline and 12 weeks)
- Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)(Baseline and 12 weeks)
研究者
Martha Sajatovic
Professor of Psychiatry
University Hospitals Cleveland Medical Center