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

Primary Purpose

Acute Stress Disorder

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Prazosin, ALPRESS® LP 2,5 et 5 mg

About this trial

This is an interventional treatment trial for Acute Stress Disorder focused on measuring Acute stress Disorder, Post Traumatic Stress Disorder, Prevention, trauma, prazosin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prazosin, ALPRESS® LP 2,5 et 5 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

PTSD diagnosis

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

Secondary Outcome Measures

Acute stress symptoms

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

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

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

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

occurrence of complications of PTSD

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

Compliance

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

Full Information

NCT ID

NCT03045016

First Posted

February 2, 2017

Last Updated

September 16, 2020

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT03045016

Brief Title

Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

Acronym

PRAZOSTRESS

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 21, 2017 (Actual)

Primary Completion Date

March 30, 2020 (Actual)

Study Completion Date

March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stress Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prazosin, ALPRESS® LP 2,5 et 5 mg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Prazosin, ALPRESS® LP 2,5 et 5 mg

Intervention Description

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 Measure Information:

Title

PTSD diagnosis

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Acute stress symptoms

Description

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

Time Frame

14 days

Title

Prazosin side effects

Description

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

Title

Prazosin side effects

Description

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

Title

Prazosin side effects

Description

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

Title

occurrence of complications of PTSD

Description

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

Time Frame

6 months

Title

Compliance

Description

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

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department

City

Lyon

ZIP/Postal Code

69003

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

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