Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index From Baseline.
研究概览
简要总结
The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.
详细描述
The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.
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, Investigator, Outcomes Assessor)
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
- •Be between the ages of 18 to 64
- •Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
- •Sleep difficulties at least 2x per week in the preceding month
- •Be on a stable dose of antipsychotic medication
- •Symptomatically stable in the last 2 months
- •English speaking.
排除标准
- •Meet criteria for current alcohol or other substance dependence
- •A history of dementia, mental retardation or other neurological disorder
- •Not capable of giving informed consent for participation in this study.
- •Ongoing pregnancy
- •Known sensitivity to zopiclone.
- •Insomnia associated with medical disorders likely to impair sleep.
- •Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
- •Lack of sleep benefit from previous adequate eszopiclone treatment
- •History of clinically significant hepatic impairment.
- •Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.
研究组 & 干预措施
Eszopiclone Group
Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
干预措施: Eszopiclone (Drug)
Placebo Group
Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Insomnia Severity Index From Baseline.
时间窗: 8 Weeks
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.
次要结局
未报告次要终点
研究者
Cenk Tek
Associate Professor
Yale University