Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in total sleep time from baseline to final visit
研究概览
简要总结
Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
详细描述
This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.
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 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline
排除标准
- •May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries
研究组 & 干预措施
Placebo
Drug: Placebo, Drug: Escitalopram 10mg or 20mg
干预措施: Placebo (Drug)
Eszopiclone
Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
干预措施: Eszopiclone (Drug)
Eszopiclone
Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg
干预措施: Escitalopram (Drug)
Placebo
Drug: Placebo, Drug: Escitalopram 10mg or 20mg
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change in total sleep time from baseline to final visit
时间窗: from baseline to final visit
次要结局
- change in sleep latency from baseline to final visit(from baseline to final visit)
- Change in HAMD from baseline to final visit(from baseline to final visit)
- Change in ISI from baseline to final visit(baseline to final visit)
- Change in CGI-S, CGI-I from baseline to final visit(baseline to final visit)
- labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height(visit 1)
- vitals: BP,pulse,temperature,weight,assess AE's/SAE's(every visit)