Eszopiclone for the Treatment of PTSD

描述（由申请人提供）：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，并与受影响个体的显着痛苦和功能障碍相关。虽然目前对PTSD的药物治疗有些有效，但大多数患者在目前的标准干预措施后仍有症状；发展新的治疗方法来治疗受影响的个体，解决了一个关键的未满足的临床需求。我们建议进行一项为期三年的研究，利用R-34机制系统评估艾司佐匹克隆治疗PTSD伴睡眠障碍的潜在疗效。该研究包括一项双盲、随机、安慰剂对照试验，在40例PTSD患者中使用非苯二氮卓类GABA受体激动剂eszopiclone，为期12周，并将检查PTSD、睡眠、抑郁和功能障碍的测量结果。此外，我们将评估治疗对活动图（作为睡眠的客观测量）、记忆的神经心理学评估和炎症标志物（细胞因子）作为反应的生物标志物以及作为中介和调节假设的一部分的影响，以解决有关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了解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.