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CompletedNCT03045016PRAZOSTRESSUpdated May 27, 2026

Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

A Phase 2 interventional study of Prazosin, ALPRESS® LP 2,5 et 5 mg in Acute Stress Disorder, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Acute Stress Disorder

Keywords

  • Acute stress Disorder
  • Post Traumatic Stress Disorder
  • Prevention
  • trauma
  • prazosin
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In context

Stress Disorders, Traumatic, Acute

57 studies on the registry are indexed under Stress Disorders, Traumatic, Acute; 15 are open to participants now.

This study's enrollment of 15 is below the median of 90 across 51 interventional studies indexed under Stress Disorders, Traumatic, Acute.

Browse Stress Disorders, Traumatic, Acute studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg

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.

06

What researchers measure

Primary outcomes

  1. PTSD diagnosis

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

    Time frame: 6 months

Secondary outcomes

  1. Acute stress symptoms

    These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria

    Time frame: 14 days

  2. 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

    Time frame: 7 days

  3. 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

    Time frame: 14 days

  4. 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

    Time frame: 1 month

  5. occurrence of complications of PTSD

    Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life.

    Time frame: 6 months

  6. Compliance

    Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin

    Time frame: 1 month

07

Study locations

1 site
  • Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department
    Lyon, 69003, France
08

References and documents

Publications

  • 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. PubMed 38154074 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03045016
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 7, 2017
Start date
Apr 21, 2017
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
May 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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