SECONDARY PREVENTION OF PTSD WITH PROPRANOLOL

使用心得安对 PTSD 进行二级预防

• 批准号: 2671128
• 负责人: ROGER K. PITMAN
• 金额: $ 25.44万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-01 至 2000-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2671128
• 关键词: SECONDARY; PREVENTION; PTSD; PROPRANOLOL

DESCRIPTION (Applicant's Abstract): The current state of post-traumatic stress disorder (PTSD mental hygiene consists largely of tertiary prevention of limited efficacy. Secondary prevention of PTSD, which to date has received little research attention, involves intervening in the aftermath of a traumatic event to forestall the disorder. Results of pre-clinical and clinical studies suggest that an acute post-traumatic hyperadrenergic state is involved in the pathogenesis of PTSD. Reduction of this hyperadrenergic state by means of beta-adrenergic blockade may prevent this disorder. The objective of the proposed work is to study the effectiveness of propranolol in preventing the development of PTSD in persons presenting to an emergency room (ER) following a traumatic event by means of a double-blind, placebo-controlled study. It is hypothesized that administration of propranolol to acutely traumatized patients in the ER and during the following days will reduce the rate of the PTSD outcome. Patients will be recruited from men and women between the ages of 18 and 65 who present to the Massachusetts General Hospital ER following an acute psychologically traumatic event and show evidence of a hyperadrenergic state as indexed by heart rate> 90. As soon as baseline psychometric and psychobiologic measures have been collected, the patient will receive the first dose of propranolol or placebo, which will be followed by ten days of twice-daily long-acting propranolol or placebo. One and three months following the traumatic event, the patient will undergo psychodiagnostic, psychometric, and psychophysiologic testing for PTSD. The 2 x 2 table of Drug (propranolol versus placebo) and three-month Outcome (PTSD versus no PTSD) will be tested for statistical significance by means of Pearson's Chi Square. Logistic regression will also be performed. Allowing for a 20 percent drop-out rate, 320 participants enrolled over a two and one-half year period and randomized on a 1:1 basis to propranolol or placebo will provide 80 percent power to detect a one-third or greater reduction by propranolol of the probability of the PTSD outcome.

描述（申请人摘要）：创伤后的现状 应激障碍（PTSD 心理卫生主要包括三级预防 功效有限。 迄今为止，PTSD 的二级预防 很少受到研究关注，涉及事后干预 预防疾病发生的创伤性事件。 临床前和临床研究的结果表明，急性 创伤后肾上腺素能亢进状态参与了发病机制 创伤后应激障碍。 通过β-肾上腺素能减少这种高肾上腺素能状态 封锁可以预防这种疾病。 拟议工作的目标是 研究普萘洛尔预防发展的有效性 创伤后应激障碍 (PTSD) 患者因创伤而被送往急诊室 (ER) 事件通过双盲、安慰剂对照研究进行。 这是 假设对急性创伤患者施用普萘洛尔 急诊室和接下来几天内的患者将降低 创伤后应激障碍的结果。 患者将从年龄在 18 岁至 65 岁之间的男性和女性中招募 在急性发作后到马萨诸塞州总医院急诊室就诊的人 心理创伤事件并显示出肾上腺素能亢进状态的证据 以心率为索引> 90。一旦基线心理测量和 已收集心理生物学措施，患者将收到 第一剂普萘洛尔或安慰剂，随后十天 每日两次长效普萘洛尔或安慰剂。 一三个月 创伤事件发生后，患者将接受心理诊断， PTSD 的心理测量和心理生理测试。 药物（普萘洛尔与安慰剂）和三个月结果的 2 x 2 表 （PTSD 与无 PTSD）将通过以下方式测试统计显着性： 皮尔逊的 Chi Square。 还将执行逻辑回归。 考虑到 20% 的退出率，320 名参与者在 为期两年半，并以 1:1 的比例随机分配给普萘洛尔或 安慰剂将提供 80% 的功效来检测三分之一或更多 普萘洛尔可降低 PTSD 结果的可能性。