Eszopiclone for the Treatment of PTSD

右佐匹克隆治疗创伤后应激障碍 (PTSD)

• 批准号: 8112172
• 负责人: MARK H POLLACK
• 金额: $ 22.95万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-09 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8112172
• 关键词: Address; Affect; Anxiety; Benzodiazepines; Biological; Biological Markers; Biology; Characteristics; Clinical; Cognitive; Data; Development; Distress; Double-Blind Method; Emotional; Eszopiclone; Evidence based treatment; Factor Analysis; Functional disorder; Future; GABA Agonists; High Prevalence; Individual; Intervention; Intervention Studies; Investigation; Lead; Learning; Measures; Mediating; Mediator of activation protein; Memory; Mental Depression; Mental disorders; Military Personnel; Moods; Outcome Measure; Patients; Placebos; Population; Post-Traumatic Stress Disorders; Prevalence; Public Health; Quality of life; Randomized; Relative (related person); Reporting; Safety; Severities; Sleep; Sleep disturbances; Sleeplessness; Symptoms; Work; actigraphy; cytokine; effective intervention; functional disability; hypnotic; inflammatory marker; memory recall; neuropsychological; novel; novel therapeutics; randomized placebo controlled trial; response; sleep abnormalities; stressor; treatment effect; treatment response

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. PUBLIC HEALTH RELEVANCE: Post Traumatic Stress Disorder (PTSD) is a common and markedly distressing and impairing condition occurring in civilian and military personnel exposed to significant traumatic stressors. Given its prevalence and morbid impact, the development of effective interventions to treat PTSD represents a critical public health need. Results of this study will provide information about the potential efficacy of a novel agent, 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，并与受影响个体的严重痛苦和功能障碍相关。尽管目前针对 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然有症状；开发治疗受影响个体的新疗法解决了未满足的关键临床需求。我们提议开展一项为期三年的研究，利用 R-34 机制来系统评估艾司佐匹克隆治疗伴有睡眠障碍的 PTSD 的潜在功效。该研究包括一项为期 12 周的双盲、随机、安慰剂对照试验，对 PTSD 患者 (n=40) 进行非苯二氮卓类 GABA 受体激动剂右佐匹克隆治疗，并检查 PTSD 以及睡眠、抑郁的测量结果和功能障碍。此外，我们将评估治疗对体动记录仪（作为睡眠的客观测量）、记忆的神经心理学评估和炎症标记物（细胞因子）的影响，作为反应的生物标记物，并作为中介和调节假设的一部分，以解决有关这种治疗如何进行的问题可能有效以及谁可以从中受益。实现这些目标将有助于为创伤后应激障碍的治疗提供信息，并且具有重要的公共卫生意义。 公共健康相关性：创伤后应激障碍 (PTSD) 是一种常见且明显令人痛苦和损害的状况，发生在暴露于严重创伤性应激源的文职和军事人员中。鉴于其患病率和病态影响，开发有效的干预措施来治疗创伤后应激障碍是一项重要的公共卫生需求。这项研究的结果将提供有关新药艾佐匹克隆治疗创伤后应激障碍的潜在功效的信息。