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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Stress Disorder
• Intervention / Treatment: Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD diagnosis	The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute stress symptoms	These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria	14 days
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	7 days
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	14 days
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	1 month
occurrence of complications of PTSD	Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life.	6 months
Compliance	Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin	1 month

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: trauma; Prevention; Post Traumatic Stress Disorder; prazosin; Acute stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Prazosin
• Other Study ID Numbers: 69HCL16_0628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No