Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

NCT03045016 | Completed Phase 2

• 1 other identifier: 69HCL16_0628
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stress Disorder

Keywords

Acute stress Disorder; Post Traumatic Stress Disorder; Prevention; trauma; prazosin

Outcome Measures

Primary Outcomes (1)

• PTSD diagnosis

  The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)

  6 months

Secondary Outcomes (6)

• Acute stress symptoms

  14 days

• Prazosin side effects

  7 days

• Prazosin side effects

  14 days

• Prazosin side effects

  1 month

• occurrence of complications of PTSD

  6 months

Study Arms (1)

Prazosin, ALPRESS® LP 2,5 et 5 mg

EXPERIMENTAL

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

Interventions

Prazosin, ALPRESS® LP 2,5 et 5 mg DRUG

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.

Prazosin, ALPRESS® LP 2,5 et 5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department

Lyon, 69003, France

Location

Related Publications (1)

• Magnin C, Poulet E, Fanton L, Vignaud P, Brunelin J. A non-randomized pilot trial of the use of prazosin in the prevention of transition from acute stress disorder to post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2251250. doi: 10.1080/20008066.2023.2251250. Epub 2023 Sep 6.

  PMID: 38154074 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 7, 2017
• Study Start: April 21, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)