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Completed

NCT Number: NCT03045016

Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PTSD diagnosis

    Time frame: 6 months

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

Secondary outcomes

  1. Acute stress symptoms

    Time frame: 14 days

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

  2. Prazosin side effects

    Time frame: 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

  3. Prazosin side effects

    Time frame: 14 days

    This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test

  4. Prazosin side effects

    Time frame: 1 month

    This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test

  5. occurrence of complications of PTSD

    Time frame: 6 months

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

  6. Compliance

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PRAZOSTRESS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2017
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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