Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Insomnia is highly prevalent in the older adult population. The pharmacolgical management of chronic insomnia includes benzodiazepines and Z-drugs (zolpidem, zopiclone). Although these drugs are indicated for insomnia, they are not without side effects. These drugs are associated with cognitive impairment, rebound insomnia, falls and addiction. Mirtazapine has a hypnotic and sedative effect related to the blocking of histamine-1 receptors. No clinical trials has evaluated the efficacy and safety of mirtazapine for insomnia in the older population.
The goal of the study is to assess the efficacy and safety of mirtazapine compared to a placebo in older adults with chronic insomnia.
This prospective double-blind placebo controlled trial will be conducted in adults 65 years and older with chronic insomnia. The treatment group will receive mirtazapine 7.5 mg at bedtime for 28 days and the control group will receive a matching placebo for 28 days. The sample size for the pilot study will be 60 subjects, 30 subjects in the treatment group and 30 subjects in the control group. The efficacy of mirtazapine will be measured using the Insomnia Severity Index and the Pittsburgh Sleep Quality Index. Safety will be monitored during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age 65 years and older
- •A report of sleep initiation or maintenance problems
- •An adequate opportunity and circumstances to sleep,
- •To have at least one daytime consequence in relation to sleep complaint.
- •Sleep disorder and daytime consequences occur at least 3 times a week.
- •Duration of sleep disorder and daytime consequences for at least 3 months
- •Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia.
排除标准
- •Contrindication to mirtazapine
- •Use of drug for insomnia
- •Cognitive Behavioural Therapy for insomnia
- •Use of Melatonin
- •Active psychiatric illness
- •Parkinson's disease
- •Major Neurocognitive disorders
- •More than one fall in the last 3 months
研究组 & 干预措施
Treatment
Mirtazapine 7.5 mg
干预措施: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime (Drug)
Control
Matching placebo
干预措施: Placebo oral tablet once daily at bedtime (Drug)
结局指标
主要结局
Insomnia Severity Index
时间窗: For Mirtazapine and placebo group : Assess the change in the Insomnia Severity Index between the initial examination (Day 1) and the end of the treatment course (Day 36)
Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome
Pittsburgh Sleep Quality Index
时间窗: For Mirtazapine and placebo group : Assess the change in the Pittsburgh Sleep Quality Index between the initial examination (Day 1) and the end of the treatment course (Day 36)
Sleep scale from 0 to 21, 21 being the worst outcome
次要结局
未报告次要终点