Medication Treatment for Depression in Nursing Home Residents
Drug Treatment of Depression in the Nursing Home Aged
研究概览
详细说明
There are approximately 1.6 million nursing home residents in the United States. More than one third of these residents are taking antidepressant medications (ADs). Although ADs are effective, evidence suggests that they can lead to significant adverse events, including an increased risk of falls and bone fractures. Many depressed nursing home residents suffer from an initial episode of late-life depression and do not meet guideline-based recommendations for maintenance treatment. This study will examine the benefits and risks of long-term AD treatment in depressed nursing home residents whose single episode of depression has been in continuous remission for at least six months.
Participants will be randomly assigned to either continue or discontinue AD treatment. Participants will be monitored over a period of one year for recurrence of depression and related symptoms, as well as for the occurrence of falls, fractures, and other adverse events. Medical chart review, self-reported mood symptoms, and depression scales will be used to assess participants.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Current use of antidepressant medication
- Have been in remission from first episode of depression for 6 months or longer
- Currently residing in a long term care or assisted living facility
Exclusion Criteria:
- Bedridden
- Severe cognitive impairment
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Randomized to drug continuation
Participants assigned to continue current antidepressant medication
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Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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Randomized to drug discontinuation
Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
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Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
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Participant preference to continue drug
Chose to continue antidepressant medication
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Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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Participant preference to discontinue drug
Chose to discontinue antidepressant medication (no antidepressant medication)
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Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Geriatric Depression Scale (GDS) Score
大体时间：Measured at Month 12
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The GDS scale measures presence and severity of depressive symptoms in older adults.
Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).
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Measured at Month 12
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Number of Falls Experienced by Participants Over Twelve Months of Surveillance
大体时间：Measured from Baseline through Month Twelve
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Measured from Baseline through Month Twelve
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cognitive Function (MMSE)
大体时间：Measured at Month 12
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The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function.
Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).
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Measured at Month 12
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合作者和调查者
调查人员
- 首席研究员：Joel E. Streim, MD、University of Pennsylvania
出版物和有用的链接
一般刊物
- Streim JE, DiFilippo S, TenHave T, Mavandadi S, Weintraub D, Oslin D. Antidepressant discontinuation associated with cognitive decline in older adult residents of long-term care facilities. Am J Geriatr Psychiatry 20(3) (supplement 1): S147-148, 2012.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Antidepressant medication的临床试验
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