Randomized Placebo-Controlled Trial of Hydrocortisone in PTSD Prophylaxis

氢化可的松预防 PTSD 的随机安慰剂对照试验

• 批准号: 8042818
• 负责人: Joseph Zohar
• 金额: $ 46.25万
• 依托单位: SHEBA RESEARCH FUND
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-04 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8042818
• 关键词: Accident and Emergency department; Acute; Alternative Therapies; Anxiety; Biological; Body Weight; Bolus Infusion; Cardiology; Circadian Rhythms; Clinical; Consent; Data; Development; Diagnosis; Discipline; Dissociation; Distress; Dose; Early treatment; Event; Excretory function; Exposure to; Fibrinolytic Agents; Gene Expression; Genes; Glucocorticoid Receptor; Glucocorticoids; Homeostasis; Hour; Hydrocortisone; Hydrocortisone/Placebo; Injection of therapeutic agent; Intervention; Interview; Intravenous; Light; Measurement; Measures; Medical; Mental Depression; Modeling; Neurology; Panic; Participant; Pattern; Persons; Phase; Physicians; Placebos; Plasma; Post-Traumatic Stress Disorders; Process; Prophylactic treatment; Randomized; Recovery; Recruitment Activity; Research; Research Personnel; Risk; Screening procedure; Secondary Prevention; Severities; Signal Transduction; Sleep; Sodium; Stress; Stroke; Survivors; Symptoms; Tacrolimus Binding Proteins; Time; Trauma; Work; active method; base; dehydroepiandrosterone; disorder prevention; double-blind placebo controlled trial; functional disability; innovation; neuropeptide Y; prevent; prospective; psychologic; randomized placebo controlled trial; resilience; response; urinary

DESCRIPTION (provided by applicant): The primary aim of the proposed project is to determine the efficacy of a single injection of 90-140 mg (proportioned to body weight) of hydrocortisone (Hcort) to prevent the subsequent development of posttraumatic stress disorder (PTSD) by engaging biological mechanisms associated with recovery within 6 hours after exposure to a traumatic event. This project also seeks to examine biological and psychological alterations associated with trauma exposure and recovery by evaluating these over time in persons randomized to Hcort or placebo. The proposed approach is an outgrowth of work performed by the investigators in their respective research settings pertaining to mechanisms involved in recovery. PUBLIC HEALTH RELEVANCE: This study, if proven effective, has the potential of revolutionizing the treatment of PTSD in the same way that administration of thrombolytic agents in the "golden hours" has changed the treatment in CVA and MI, and will move the treatment of PTSD from treatment to secondary prevention.

描述（由申请人提供）：拟议项目的主要目的是确定单次注射90-140 mg（与体重成比例）氢化可的松（Hcort）的有效性，以通过在暴露于创伤事件后6小时内参与与恢复相关的生物学机制来预防创伤后应激障碍（PTSD）的后续发展。该项目还试图通过在随机分配到Hcort或安慰剂组的人中评估这些随时间的变化，来检查与创伤暴露和恢复相关的生物和心理变化。所提出的方法是调查人员在各自的研究环境中进行的有关恢复机制的工作的结果。 公共卫生相关性：这项研究，如果被证明是有效的，有可能彻底改变创伤后应激障碍的治疗，就像在“黄金时间”给予溶栓药物改变了CVA和MI的治疗一样，并将创伤后应激障碍的治疗从治疗转向二级预防。