Escitalopram in the Treatment of Patients With Agitated Dementia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Agitation factor on the Neurobehavioral Rating Scale (NBRS)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.
详细描述
This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia of Alzheimer's type with behavioral disturbance
- •Mild to severe cognitive impairment
- •Age over 60
- •Medically stable
- •Agitation present both at screening and baseline
- •Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
- •Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
- •No planned change in environment for duration of study
- •At least one reliable caregiver
排除标准
- •Any intercurrent medical problem that could explain the agitation
- •History of major depression or bipolar preceding the onset of dementia
- •Other major psychiatric illness preceding the onset of dementia or mental retardation
- •Other dementias
- •History of alcohol abuse or dependence in the last 2 years
- •Delirium (or history of delirium in the last 8 weeks)
- •Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
- •Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
- •Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
- •History of intolerance to citalopram
- •Noncompliance with oral medication or inability to take oral medication
- •Modified Hachinski score of 4 or greater
结局指标
主要结局
Agitation factor on the Neurobehavioral Rating Scale (NBRS)
次要结局
- Total NBRS scores
- Cohen-Mansfield Agitation Inventory
- Neuropsychiatric Inventory
- Global Clinical Impression of Change