Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

NCT ID: NCT03045016

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2020-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prazosin, ALPRESS® LP 2,5 et 5 mg

Intervention Type: 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.

Interventions

Prazosin, 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department

Lyon, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 38154074 (View on PubMed)

Other Identifiers

69HCL16_0628

Identifier Type: -

Identifier Source: org_study_id