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Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder (PRAZOSTRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045016
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Acute Stress Disorder Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : October 21, 2020
Estimated Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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 Outcome Measures :
  1. PTSD diagnosis [ Time Frame: 6 months ]
    The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045016


Contacts
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Contact: Emmanuel POULET, MD, PhD +33 472 110 009 emmanuel.poulet@chu-lyon.fr
Contact: Charline MAGNIN, Student charline.magnin@chu-lyon.fr

Locations
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France
Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department Recruiting
Lyon, France, 69003
Contact: Emmanuel POULET, MD, PhD    +33 472 110 009    emmanuel.poulet@chu-lyon.fr   
Contact: Charline MAGNIN, Sudent       charline.magnin@orange.fr   
Principal Investigator: Emmanuel POULET, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03045016    
Other Study ID Numbers: 69HCL16_0628
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Acute stress Disorder
Post Traumatic Stress Disorder
Prevention
trauma
prazosin
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs