Acute Stress DisorderPhase 2PRAZOSTRESSNCT03045016
Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder
A Phase 2 study testing Prazosin, ALPRESS® LP 2,5 et 5 mg in people with Acute Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Stress Disorder
- What is being tested?
- Prazosin, ALPRESS® LP 2,5 et 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2017to 30 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department
Lyon, 69003
About this study
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
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.
- Conditions
- Acute Stress Disorder
- Being tested
- Prazosin, ALPRESS® LP 2,5 et 5 mg
- Keywords
- Acute stress Disorder, Post Traumatic Stress Disorder, Prevention, trauma, prazosin
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prazosin, ALPRESS® LP 2,5 et 5 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prazosin, ALPRESS® LP 2,5 et 5 mg | Experimental | 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. Receives: Drug: Prazosin, ALPRESS® LP 2,5 et 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnosis
The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)
Measured: 6 months
Secondary outcomes (6)
Acute stress symptoms
These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month
occurrence of complications of PTSD
Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life.
Measured: 6 months
Compliance
Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start21 Apr 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045016
- Sponsor's protocol ID
- 69HCL16_0628
- Other IDs
- 2016-004653-32, 2016
- Acronym
- PRAZOSTRESS
- Status last verified
- May 2026
- First submitted
- 2 Feb 2017
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magnin C, Poulet E, Fanton L, Vignaud P, Brunelin J. A non-randomized pilot trial of the use of prazosin in the prevention of transition from acute stress disorder to post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2251250. doi: 10.1080/20008066.2023.2251250. Epub 2023 Sep 6.
PubMed 38154074
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03045016
- Acronym / sponsor ID
- PRAZOSTRESS / 69HCL16_0628
- Conditions
- Acute Stress Disorder
- Keywords
- Acute stress Disorder, Post Traumatic Stress Disorder, Prevention, trauma, prazosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prazosin, ALPRESS® LP 2,5 et 5 mg | Experimental | Drug: Prazosin, ALPRESS® LP 2,5 et 5 mgPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prazosin, ALPRESS® LP 2,5 et 5 mgPatients 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. | Drug | Prazosin, ALPRESS® LP 2,5 et 5 mg |
Primary outcome
PTSD diagnosis
Time frame: 6 months
The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS)
6 secondary outcomes
Acute stress symptoms
Time frame: 14 days
Prazosin side effects
Time frame: 7 days
Prazosin side effects
Time frame: 14 days
Prazosin side effects
Time frame: 1 month
occurrence of complications of PTSD
Time frame: 6 months
Compliance
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 38154074Magnin C, Poulet E, Fanton L, Vignaud P, Brunelin J. A non-randomized pilot trial of the use of prazosin in the prevention of transition from acute stress disorder to post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2251250. doi: 10.1080/20008066.2023.2251250. Epub 2023 Sep 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prazosin, ALPRESS® LP 2,5 et 5 mg in people with Acute Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.