The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
研究概览
简要总结
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
详细描述
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Escitalopram oxalate 10 mg at bedtime
干预措施: Eszopiclone (Lunesta) (Drug)
2
Eszopiclone 3 mg at bedtime
干预措施: Eszopiclone (Lunesta) (Drug)
结局指标
主要结局
The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
时间窗: 8 weeks
次要结局
- Change from baseline in subjective total sleep time averaged over the double blind treatment period.(8 weeks)