Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

Phase 2

Completed

• Conditions: Acute Stress Disorder
• Interventions: Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg

• Registration Number: NCT03045016
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Study Start: 2017-04-21
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prazosin, ALPRESS® LP 2,5 et 5 mg	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.

Primary Outcome Measures

Name	Time	Method
PTSD diagnosis	6 months	The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department; 🇫🇷 Lyon, France