Aripiprazole in Late Life Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Weight
研究概览
简要总结
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).
详细描述
While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders.
Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
- •Must be age 50 or older
- •Must have sub-optimal response to current psychotropic management including at least one of the following:
- •Behaviors and symptoms of irritability, agitation, mood liability 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 bipolar disorder
- •Intolerance to current psychotropic medications; and
- •Must live in the Northeast Ohio area.
排除标准
- •An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
- •DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
- •Receiving carbamazepine.
研究组 & 干预措施
1
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Weight
时间窗: 12 weeks
Electrocardiogram - screening and 12/study end
时间窗: 12 weeks
Complete blood count (CBC) with differential - screening and 12/study end
时间窗: 12 weeks
Abnormal Involuntary Movement Scale (AIMS)
时间窗: 12 weeks
Blood pressure and pulse
时间窗: 12 weeks
Barnes Akathisia Scale (BAS)
时间窗: 12 weeks
Simpson Angus Neurological Rating Scale (SAS)
时间窗: 12 weeks
Basic serum chemistry - screening and 12/study end
时间窗: 12 weeks
Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
时间窗: 12 weeks
Clinical Global Impression (CGI)
时间窗: 12 weeks
Global Assessment Scale (GAS)
时间窗: 12 weeks
Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
时间窗: 12 weeks
次要结局
未报告次要终点