Identification of Novel Agents to Treat PTSD using Clinical Data

项目总结 这项研究将利用退伍军人事务部(VA)的大规模临床数据来确定 现有的药物通常用于多种适应症的处方，这些适应症是偶然发生的 与创伤后应激障碍(PTSD)症状改善有关。经过前期的努力，一个 数据源包含所有(100多万)退伍军人管理局被诊断为 1999年10月至2018年2月期间的创伤后应激障碍已建立，包括完整的历史记录 他们在退伍军人管理局医疗系统内的循证药物和心理治疗收据。重要的是 该团队还收集了数十万名创伤后应激障碍患者报告的症状级别结果数据 这些病人。现有的数据是一个强大的资源，研究小组建议用它来探索 以下具体目标：(1)确定与创伤后应激障碍改善有关的非标签药物 症状随时间的推移；(2)进一步评估新发现的非标签药物的临床疗效 使用严格的因果方法改善创伤后应激障碍症状的药物；以及(3)确定常见的不良反应 与非标签药物相关的事件与本研究中PTSD症状的改善相关 复杂的、患有精神疾病和内科疾病的人群拟议的项目将确定可能值得 进一步严格的临床评估，以获得精神益处。可能会确定新的治疗靶点， 导致更多的治疗选择或特定的治疗。此外，对标签外药物的识别 改善或具有精神疾病人群的禁忌症效果将为实践提供关键指导 临床医生。

PROJECT SUMMARY This study will leverage large-scale clinical data from the Department of Veterans Affairs (VA) to identify existing pharmaceutical agents commonly prescribed for a multitude of indications that are incidentally associated with improvements in post-traumatic stress disorder (PTSD) symptoms. Through prior efforts, a data source containing almost 20 years of treatment data on all (over one million) VA users diagnosed with PTSD between October 1999 and February 2018 has been constructed, including a complete historical record of their evidence-based medication and psychotherapy receipt within the VA healthcare system. Importantly, the team has also amassed symptom-level patient-reported PTSD outcome data for hundreds of thousands of these patients. The existing data is a powerful resource with which the research team proposes to explore the following specific aims: (1) identify off-label pharmaceutical agents associated with improvements in PTSD symptoms over time; (2) further evaluate the clinical effectiveness of newly-identified off-label pharmaceutical agents for improvement in PTSD symptoms using rigorous causal methods; and (3) identify common adverse events related to off-label pharmaceutical agents associated with improvements in PTSD symptoms in this complex, psychiatrically and medically ill population The proposed project will identify agents that may merit further rigorous clinical evaluation for psychiatric benefit. New therapeutic targets may be identified that will lead to greater treatment options or specific treatments. Further, identification of off-label medications that improve or have contraindicated effects for psychiatric populations will provide critical guidance to practicing clinicians.