Sleep-dependent Memory Processing in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Sleep Spindle Density
研究概览
简要总结
The investigators will test the hypothesis that the sleep medication, eszopiclone, can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance on two conditions separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will study healthy subjects and chronic, medicated outpatients with schizophrenia.
详细描述
Sleep spindles, a defining oscillation of stage 2 non-rapid eye movement sleep (N2), are strongly linked to memory and IQ in healthy individuals. Schizophrenia is characterized by a spindle deficit that correlates with deficient sleep-dependent memory consolidation, symptom severity, IQ and executive function. In a small pilot study of schizophrenia patients, eszopiclone , significantly increased sleep spindles but its effect on memory was not significant. Here, in a larger double-blind, placebo-controlled, cross-over design study, we investigated whether eszopiclone can both increase spindle density and improve memory consolidation. Chronic, medicated schizophrenia outpatients and demographically-matched healthy control participants were randomly assigned to receive either placebo first or 3mg of eszopiclone first for two consecutive nights with high density polysomnography. Placebo and eszopiclone visits were one week apart. Participants were trained on the Motor Sequence Task (MST) at bedtime of the second night of each visit and tested the following morning to probe sleep-dependent motor memory consolidation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •clinically stable outpatients with schizophrenia,
- •proficient in English,
- •able to give informed consent,
- •maintained on a stable dose of atypical antipsychotic medications for at least 6 weeks prior to enrollment.
- •healthy Control participants matched as a group to the patients for age, sex, and parental socioeconomic status.
排除标准
- •Substance abuse or dependence within the past six months;
- •other chronic medical conditions that affect sleep; (- pregnancy/breast feeding;
- •hepatic impairment;
- •treatment with inhibitors or inducers of CYP 3A4 or 2E1 enzymes (which metabolize eszopiclone);
- •a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae; (- mental retardation; (- a diagnosed sleep disorder other than insomnia,
- •neurological disorder; sleep disorder, other than insomnia, identified in a clinical sleep evaluation.
- •Patients on conventional agents, benzodiazepines, or other sleep agents will be excluded. Potential controls will be excluded for a personal history of mental illness, a family history of schizophrenia spectrum disorder or psychosis, and treatment with medications known to affect sleep or cognition.
研究组 & 干预措施
Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
干预措施: placebo (Drug)
Schizophrenia
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia.
All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
干预措施: eszopiclone (Drug)
Schizophrenia
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia.
All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
干预措施: placebo (Drug)
Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
干预措施: eszopiclone (Drug)
结局指标
主要结局
Sleep Spindle Density
时间窗: Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)
This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.
次要结局
- Motor Procedural Memory Performance(Experimental Night (Night 2))
研究者
Dara S. Manoach, PhD
Professor of Psychology, Dept. of Psychiatry
Massachusetts General Hospital