Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03045016
• Date of registration: 02/02/2017
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder PRAZOSTRESS
• Scientific title: Preliminary Study About the Efficacy of an a1 Blocker (Prazosin) in Preventing the Occurrence of Post-traumatic Stress Disorder (PTSD) in Patients With Acute Stress
• Date of first enrolment: April 21, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03045016
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Stress Disorder

Intervention(s)

Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg

Primary Outcome(s)

PTSD diagnosis [Time Frame: 6 months]

Secondary Outcome(s)

Acute stress symptoms [Time Frame: 14 days]

Compliance [Time Frame: 1 month]

Prazosin side effects [Time Frame: 1 month]

occurrence of complications of PTSD [Time Frame: 6 months]

Prazosin side effects [Time Frame: 7 days]

Prazosin side effects [Time Frame: 14 days]

Secondary ID(s)

69HCL16_0628

Source(s) of Monetary Support

Please refer to primary and secondary sponsors