Acute Stress Disorder
Conditions
Keywords
Acute stress Disorder, Post Traumatic Stress Disorder, Prevention, trauma, prazosin
Brief summary
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.
Interventions
DRUGPrazosin, ALPRESS® LP 2,5 et 5 mg
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD diagnosis | 6 months | The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute stress symptoms | 14 days | These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria |
| Prazosin side effects | 7 days | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test |
| occurrence of complications of PTSD | 6 months | Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life. |
| Compliance | 1 month | Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin |
Countries
France
Outcome results
None listed