Eszopiclone for the Treatment of PTSD

描述(申请人提供)：创伤后应激障碍(PTSD)是人群中最常见的精神疾病之一，影响平民和军事人员，并与受影响个人的严重痛苦和功能障碍有关。尽管目前可用的治疗创伤后应激障碍的药物治疗在某种程度上是有效的，但大多数患者在目前的标准干预后仍然有症状；治疗受影响个人的新疗法的开发解决了一个关键的未得到满足的临床需求。我们建议进行一项为期三年的研究，利用R-34机制系统地评估埃索匹克隆治疗伴有睡眠障碍的创伤后应激障碍的潜在疗效。这项研究包括一项为期12周的双盲、随机、安慰剂对照试验，用非苯二氮卓类GABA受体激动剂埃索匹隆治疗PTSD患者(n=40)，并将检查PTSD以及睡眠、抑郁和功能障碍的结果。此外，我们将评估治疗对活动描记(作为睡眠的客观衡量标准)、记忆的神经心理学评估以及炎症标记物(细胞因子)的影响，作为反应的生物标记物，作为调节和调节假设的一部分，以解决关于这种治疗如何起作用以及谁可能从中受益的问题。解决这些目标将有助于指导创伤后应激障碍的治疗，并具有重要的公共卫生意义。

DESCRIPTION (provided by applicant): Post Traumatic Stress Disorder (PTSD) is among the most common psychiatric conditions in the population, affecting both civilians and military personnel, and is associated with significant distress and dysfunction in affected individuals. Although currently available pharmacologic treatments for PTSD are somewhat efficacious, most patients remain symptomatic after currently standard interventions; the development of novel therapeutics to treat affected individuals addresses a critical unmet clinical need. We are proposing a three-year study utilizing the R-34 mechanism to systematically assess the potential efficacy of eszopiclone for the treatment of PTSD with sleep disturbance. The study comprises a double blind, randomized, placebo controlled trial over 12 weeks of the non- benzodiazepine GABA receptor agonist eszopiclone in patients (n=40) with PTSD, and will include examination of outcomes for measures of PTSD as well as sleep, depression, and functional impairment. Further, we will assess the impact of treatment on actigraphy (as an objective measure of sleep), neuropsychological assessments of memory, and inflammatory markers (cytokines) as biomarkers of response and as part of mediator and moderator hypotheses to address questions about how this treatment may work and who might benefit from it. Addressing these aims will help inform the treatment of PTSD and have important public health significance.