Drug Treatment of Depression in the Nursing Home Aged
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Geriatric Depression Scale (GDS) Score
研究概览
简要总结
This study will examine therapeutic and adverse effects of continuing versus discontinuing antidepressant medication in nursing home residents who have had no more than a single episode of depression and who no longer have depressive symptoms.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Bedridden
- •Severe cognitive impairment
研究组 & 干预措施
Randomized to drug continuation
Participants assigned to continue current antidepressant medication
干预措施: Antidepressant medication (Drug)
Randomized to drug discontinuation
Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
干预措施: No antidepressant medication (Drug)
Participant preference to continue drug
Chose to continue antidepressant medication
干预措施: Antidepressant medication (Drug)
Participant preference to discontinue drug
Chose to discontinue antidepressant medication (no antidepressant medication)
干预措施: No antidepressant medication (Drug)
结局指标
主要结局
Geriatric Depression Scale (GDS) Score
时间窗: Measured at Month 12
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).
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
时间窗: Measured from Baseline through Month Twelve
次要结局
- Cognitive Function (MMSE)(Measured at Month 12)