Preliminary Study About the Efficacy of an α1 Blocker (Prazosin) in Preventing the Occurrence of Post-traumatic Stress Disorder (PTSD) in Patients With Acute Stress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- PTSD diagnosis
研究概览
简要总结
After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of age >18 years and <65 years
- •Victim of direct experience trauma (accident or physical aggression)
- •Presence of an ASD between D3 and D7 after the trauma according to DSM V criteria
排除标准
- •Contra-indication to prazosin: orthostatic hypotension, right heart failure, other hypotensive therapy, 5-phosphodiesterase inhibitors (sildenafil) or diuretic, history of syncope or severe unexplained faintness, hypersensitivity known to quinazolines.
- •Alcohol and / or drug use at the time of the trauma
- •History of psychotic disorder
- •Suicidal risk defined by a score ≥ 2 on the Suicidal Ideas Item of the Beck Depression Inventory (BDI)
- •Protected or vulnerable Major
- •Persistence of a life threatening injury at D3
- •Sexual assault
- •Only moderate head trauma can be included and therefore excluded patients with loss of consciousness greater than 30 minutes, Glasgow score less than 13, post-traumatic amnesia greater than 24 hours (Ruff et al., 2009) .
- •Prescription of morphine or morphine derivative in progress
- •Pregnancy or breastfeeding period
- •Lack of effective contraception in a woman susceptible to childbearing
- •Known hepatic dysfunction
- •Narcolepsy (Gelineau's disease)
- •Cardiac or vascular history including coronary artery disease
- •Strict low-sodium diet
研究组 & 干预措施
Prazosin, ALPRESS® LP 2,5 et 5 mg
Patients included in this study will be adults with acute stress as a result of a direct experience traumatic event. They will be treated with Prazosin, ALPRESS® LP 2,5 et 5 mg during 28 days.
干预措施: Prazosin, ALPRESS® LP 2,5 et 5 mg (Drug)
结局指标
主要结局
PTSD diagnosis
时间窗: 6 months
The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)
次要结局
- occurrence of complications of PTSD(6 months)
- Acute stress symptoms(14 days)
- Prazosin side effects(1 month)
- Compliance(1 month)