Eszopiclone for the Treatment of PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
研究概览
简要总结
The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep disturbance. The investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and level of inflammatory markers (cytokines). The investigators predict eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms, memory recall bias, and level of inflammatory markers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients age 18-65 with a primary diagnosis of PTSD and associated sleep disturbance
- •Good physical health
- •Willingness and ability to comply with the requirements of the study protocol
排除标准
- •Women pregnant, lactating, or of childbearing potential not using medically accepted contraception
- •Concurrent use of other psychotropic medications at least two weeks prior to baseline
- •Concurrent use of other anti-inflammatory medications or anti-cytokine medications. If used on an as-needed (PRN) basis, subjects may enter the study, but will be excluded from cytokine analyses
- •Concurrent use of beta-blockers less than one month prior to baseline
- •Serious medical illness or instability for which hospitalization may be likely within the next year
- •Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
- •Sleep apnea or restless leg syndrome
- •Concurrent psychotherapy initiated within 3 months of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
- •Patients with significant suicidal ideation
- •Current legal actions related to trauma or an ongoing relationship with assailant
研究组 & 干预措施
Eszopiclone
The total study duration is 16 weeks, with subjects taking 3mg eszopiclone at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
干预措施: Eszopiclone (Drug)
Placebo
The total study duration is 16 weeks, with subjects taking placebo at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
时间窗: Between Baseline and Week 12
The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology.
次要结局
- Cytokine Inflammatory Markers(Week 12)
- Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)(Changes in total score between Baseline and Week 12 (range of 0 to 21 worse))
- Changes in Emotional Bias Memory Encoding Between Baseline and Week 12(Baseline and week 12)
- Cytokine Inflammatory Marker on Interleukin-2(Week 12)