Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

Acute Stress Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045016
• Other study ID #: 69HCL16_0628
• Status: Completed
• Phase: Phase 2
• Start date: April 21, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stress Disorder
• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

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.

Locations

Country	Name	City	State
France	Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD diagnosis	The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)	6 months
Secondary	Acute stress symptoms	These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria	14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	occurrence of complications of PTSD	Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life.	6 months
Secondary	Compliance	Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin	1 month