Early Pharmacological Intervention With Diazepam in the Emergency Room Setting to Prevent Posttraumatic Stress Disorder (PTSD).
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinician Administered Posttraumatic Scale (CAPS)
研究概览
简要总结
PTSD is a pervasive and frequent disorder. Early psychological treatment - but not pharmacology - effectively prevent PTSD.
Current pharmacological studies did not include treatment given immediately after trauma exposure.
However, a recent study of opiates suggests that their early administration may reduce the likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) - within an adequate window of time.
Benzodiazepines are often used to reduce anxiety and agitation during stressful situations - including traumatic event.
These compounds may increase the likelihood of developing PTSD when administered few days after the traumatic event - but their effect as an immediate intervention has not been studied - despite their frequent and uninformed use at this stage.
This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory following traumatic event in a randomized controlled design.
Following the studies of opiates it is hoped that diazepam, administered within hours of the traumatic event, and before the first night sleep (a memory consolidating condition) will reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and thus the investigators posit a bidirectional hypothesis.
The importance of this work is that it will provide the necessary evidence to sanction a frequently practiced use of benzodiazepines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 67 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients that have experienced an acute event that meets the DSM-IV A.1 PTSD criterion: "the person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self or others;"
- •Outpatients that also meet DSM-IV A.
- •PTSD criterion: "the person's response involved intense fear, helplessness, or horror;" and
- •Outpatients that have a heart rate upon ED presentation >80 BPM
- •Outpatients that hadn't fallen asleep for a night after traumatic event before ED arrival;
排除标准
- •Physical injury that requires hospitalization, interferes with a patient's ability to cooperate with screening or give informed consent, or otherwise contraindicates participation;
- •Traumatic event reflecting ongoing victimization (e.g., domestic violence) to which the patient is likely to be re-exposed during the study period;
- •Head injury with loss of consciousness or amnesia;
- •Medical condition that contraindicates the administration of diazepam :
- •hepatic insufficiency, severe
- •hypersensitivity to diazepam
- •myasthenia gravis
- •narrow-angle glaucoma, acute
- •respiratory insufficiency, severe
- •sleep apnea syndrome
- •Current use of medication that may involve potentially dangerous interactions with diazepam, including opioids, barbitals and another benzodiazepines; when used in combination, these drugs have additive CNS and respiratory depressant effects
- •Women who are currently pregnant or nursing.
- •Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
- •Overt psychopathology, substance abuse/dependence, intoxication, odor of alcohol, or discernible substance effect;
研究组 & 干预措施
Placebo
Placebo capsule in ER, identical follow up like those in the active arm.
干预措施: Diazepam (Drug)
Diazepam
10 mg of Diazepam mg orally at ER only (a single administration)
干预措施: Diazepam (Drug)
结局指标
主要结局
Clinician Administered Posttraumatic Scale (CAPS)
时间窗: 20 minutes
Is a structured clinical interview that evaluates the 17 DSM-IV PTSD and associated symptoms on dimensions of frequency and intensity (0-4 scale for each). The CAPS also includes measures of global response validity, global PTSD symptom severity, and impact of symptoms on occupational and global functioning. The CAPS contains explicit, behaviorally anchored prompt questions and rating scale descriptors to enhance reliability.
次要结局
未报告次要终点
研究者
Pablo Roitman
MD
Hadassah Medical Organization
