Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Stress Disorder

Intervention / Treatment
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* Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prazosin, ALPRESS® LP 2,5 et 5 mg<br>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. | Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg<br>* Patients will take Prazosin during 28 days ; there are two periods of treatment (escalation of doses): PERIOD 1 (Day 0 - Day 7): 1 tablet of ALPRESS LP 2.5 mg (Prazosin) at bedtime for 7 days PERIOD 2 (Day 8 - Day 27): 1 morning tablet of ALPRESS LP 5 mg (Prazosin) at bedtime for 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD diagnosis | The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute stress symptoms | These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria | 14 days | 
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test | 7 days | 
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test | 14 days | 
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test | 1 month | 
| occurrence of complications of PTSD | Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life. | 6 months | 
| Compliance | Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prazosin, Post Traumatic Stress Disorder, Prevention, trauma, Acute stress Disorder