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SECONDARY PREVENTION OF PTSD WITH PROPRANOLOL

使用心得安对 PTSD 进行二级预防

基本信息

批准号：
2891108
负责人：
ROGER K. PITMAN
金额：
$ 25.65万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-09-01 至 2002-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2891108
关键词：
SECONDARY PREVENTION PTSD PROPRANOLOL

项目摘要

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（申请人的摘要）：创伤后精神障碍的现状应激障碍（PTSD）心理卫生主要包括三级预防功效有限。 PTSD的二级预防，迄今为止，很少受到研究的关注，涉及干预的后果，一个创伤性事件来阻止这种紊乱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创伤后应激障碍通过β-肾上腺素能受体减少这种肾上腺素能亢进状态阻断可以防止这种紊乱。拟议工作的目标是研究普萘洛尔在预防创伤后应激障碍的人提出了一个急诊室（ER）后，通过一项双盲、安慰剂对照研究确定事件。是假设普萘洛尔给急性创伤患者在急诊室和接下来的几天里，患者将减少 PTSD结局。患者将从18至65岁的男性和女性中招募他们在急性脑梗死后到马萨诸塞州总医院急诊室就诊，心理创伤事件，并显示肾上腺素能亢进状态的证据以心率为指数> 90。一旦基线心理测量和收集了心理生物学指标后，患者将接受普萘洛尔或安慰剂的第一次剂量，随后将进行10天的每天两次长效普萘洛尔或安慰剂。一至三个月在创伤事件之后，患者将接受心理诊断，心理测量和心理生理测试药物（普萘洛尔与安慰剂）和3个月结局的2 x 2表格 (PTSD与无创伤后应激障碍相比）的统计学显著性将通过平均皮尔逊X平方分布还将进行Logistic回归。考虑到20%的辍学率，320名参与者参加了一个多月的课程。为期两年半，并按1：1的比例随机分配至普萘洛尔组或安慰剂将提供80%的功效来检测三分之一或更多的普萘洛尔降低PTSD结局的概率。