Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Short PTSD Rating Interview (SPRINT)
研究概览
简要总结
The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.
详细描述
Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related problems are listed in two of them: difficulty falling asleep is considered an aspect of hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD. This study will determine the safety, efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance
排除标准
- •Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
- •Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
- •Serious medical illness or instability
- •Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
- •Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
- •Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
- •Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake
研究组 & 干预措施
Eszopiclone
Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
干预措施: Eszopiclone (Drug)
Placebo
Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
干预措施: Eszopiclone (Drug)
结局指标
主要结局
Short PTSD Rating Interview (SPRINT)
时间窗: 8 weeks
The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 8 weeks
The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.
次要结局
- Sleep Latency(8 weeks)
- Total Sleep Time(8 weeks)
- Clinician-Administered PTSD Scale (CAPS)(Week 3)
研究者
Mark H. Pollack
Grainger Professor and Chairman
Massachusetts General Hospital