Prevention of Post-Stroke Depression - Treatment Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Incidence of depressive disorders in the study population
研究概览
简要总结
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
详细描述
The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.
Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 31 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke within the last 120 days
排除标准
- •DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
- •Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
- •Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
- •Pre-existing dementia or aphasia with severe language comprehension deficits
- •Alcohol or substance abuse or dependence within the last 12 months
- •Recurrent unipolar or bipolar disorder prior to the stroke
研究组 & 干预措施
1 Problem Solving Therapy
Participants will receive problem solving therapy.
干预措施: Problem Solving Therapy (Behavioral)
2. Escitalopram
Participants will receive escitalopram.
干预措施: Escitalopram (Drug)
3 Placebo
Participants will receive placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of depressive disorders in the study population
时间窗: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
次要结局
- Functional Independence Measure(Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18)
- Stroke Impact Scale(Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
- Neurocognitive tests of executive functions and speed of information processing(Measured at baseline and after 12 months)
研究者
Robert G. Robinson
Professor
University of Iowa