Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overnight Change on Finger Tapping Task
研究概览
简要总结
This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia
排除标准
- •History of neurologic or psychiatric disease other than schizophrenia
- •Substance abuse or dependence within the past six months
- •Other chronic medical conditions that affect sleep
- •Pregnancy/breast feeding
- •Hepatic impairment
- •Treatment with metabolic inhibitors or inducers
研究组 & 干预措施
Eszopiclone
3mg of eszopiclone on two consecutive nights
干预措施: eszopiclone (Drug)
placebo
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
干预措施: placebo (Drug)
结局指标
主要结局
Overnight Change on Finger Tapping Task
时间窗: Train on Day 3 and Test on Day 4 of study (experimental nights)
The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
时间窗: during two nights in an inpatient Clinical Research Center
2 baseline nights (Days 1 \&2); 2 experimental nights (Days 3 \&4)
次要结局
未报告次要终点
研究者
Dara S. Manoach, PhD
Associate Professor of Psychology, Dept. of Psychiatry
Massachusetts General Hospital