Identification of Novel Agents to Treat PTSD using Clinical Data

利用临床数据鉴定治疗 PTSD 的新药

• 批准号: 10371100
• 负责人: Jaimie L. Gradus
• 金额: $ 55.58万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10371100
• 关键词: Accounting; Address; Adverse event; Antidepressive Agents; Biological Psychiatry; Clinical Data; Clinical effectiveness; Complex; Data; Data Set; Data Sources; Development; Diagnosis; Disease remission; Drug Prescriptions; Effectiveness; Evaluation; Fluoxetine; Future; Healthcare Systems; Label; Leadership; Medical; Medical Records; Methods; National Institute of Mental Health; Outcome; Paroxetine; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Population; Post-Traumatic Stress Disorders; Probability; Process; Psychopharmacology; Psychotherapy; Psychotropic Drugs; Publishing; Registries; Reporting; Research; Resources; Retrospective cohort; Scanning; Sertraline; Severities; Symptoms; Therapeutic Agents; Time; Trees; United States Department of Veterans Affairs; United States Food and Drug Administration; Veterans; Weight; Work; base; comorbidity; data mining; data resource; design; effective therapy; evidence base; evidence based guidelines; improved; machine learning method; military veteran; new therapeutic target; novel; novel therapeutics; off-label drug; prospective; psychopharmacologic; research clinical testing; response; symptomatic improvement; therapy development; treatment guidelines; venlafaxine; working group

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.

项目概要 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 现有的药物制剂通常用于治疗多种适应症，但这些适应症 与创伤后应激障碍（PTSD）症状的改善相关。通过前期的努力， 数据源包含所有（超过一百万）VA 用户近 20 年的治疗数据 构建了1999年10月至2018年2月之间的PTSD，包括完整的历史记录 他们在 VA 医疗保健系统内接受的循证药物和心理治疗。重要的是， 该团队还收集了数十万患者的症状水平患者报告的 PTSD 结果数据 这些病人。现有数据是研究团队建议探索的强大资源 以下具体目标：(1) 确定与改善 PTSD 相关的标签外药物 随着时间的推移出现症状； （2）进一步评价新认定的超说明书药品的临床有效性 使用严格的因果方法改善 PTSD 症状的药物； (3) 识别常见不良反应 与与 PTSD 症状改善相关的标签外药剂相关的事件 复杂的、精神科和医学疾病人群 拟议的项目将确定可能值得的药物 进一步严格的临床评估精神科益处。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，识别标签外药物 改善或对精神病人群产生禁忌影响将为实践提供重要指导 临床医生。