PTSD - Post Traumatic Stress DisorderPhase 2PPRESVISENCT07452978
Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence
A Phase 2 study testing Propranolol, 120mg in people with PTSD - Post Traumatic Stress Disorder, run by University Hospital, Tours.
Trial summary
The goal of this clinical trial is to evaluate the effect of early propranolol administration on the occurrence of post-traumatic stress disorder (PTSD) symptoms at five weeks in adult female victims of sexual violence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Propranolol, 120mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female, cisgender
- >= 18 years
- The patient agrees to comply with the contraception requirements detailed in the protocol.
- SBP > 10 cmHg
- Heart rate >= 55 bpm
- Received for consultation regarding sexual violence at the Medical-Legal Unit (UMJ) for sexual assault and/or rape within 72 hours of the incident occurring.
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- Affiliated with a social security system
- Patient who understands and reads french
- Free, informed, and written consent signed by the participant
Who cannot join
- Protected adult (guardianship, curatorship, judicial protection)
- Repeated or chronic sexual violence
- Impaired consciousness or alertness, amnesia regarding events
- Known hypersensitivity to propranolol or treated asthma, even if only occasional
- Known interactions with Propranolol (combinations not recommended and combinations to be used with caution) indicated in the summary of product characteristics
- Patients who have suffered head trauma within the last year or who have clinical symptoms and neurological sequelae
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- Patient with myasthenia gravis, with a personal history of psoriasis
- Patient wearing contact lenses
- Patient with severe liver disease and/or significant renal impairment
- Current use of a beta-blocker, regardless of dosage form.
- Current use of a drug that has a contraindicated or inadvisable drug interaction with propranolol: bepridil, diltiazem, verapamil, fingolimod.
- Addiction: presence of a current disorder related to the use of psychoactive substances.
- Current treatment with benzodiazepines
- Individuals currently receiving psychotropic treatment such as antipsychotics or antidepressants.
- People with known current or past serious psychiatric disorders.
- High suicide risk, i.e., participants who responded positively to items 4 or 5 of the C-SSRS suicidal ideation scale or any positive assessment of suicidal behavior in the 6 months prior to selection.
- Patients who have previously been diagnosed with PTSD.
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence: A Single-Center Randomized Placebo-Controlled Pilot Study
The goal of this clinical trial is to evaluate the effect of early propranolol administration on the occurrence of post-traumatic stress disorder (PTSD) symptoms at five weeks in adult female victims of sexual violence.
The investigators hypothesize that propranolol administration may reduce the traumatic emotional experience associated with the memory by positively modulating neurovegetative symptoms during the memory reconsolidation phase, thereby decreasing the risk of developing post-traumatic stress disorder (PTSD). This specific context of sexual violence appears particularly suitable, given the timeline of events, to evaluate the pharmacological efficacy of propranolol on memory reconsolidation and the prevention of post-traumatic symptom development.
Read more
Participants will :
- take Propranolol, 120mg per day divided into 3 daily doses of 40mg or a placebo for 10 days, followed by a tapering phase consisting of two daily doses of 40 mg for 7 days, and then a single daily dose of 40 mg for an additional 7 days.
- Complete questionnaires
- Complete a patient follow-up diary documenting information related to the occurrence of adverse events.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Propranolol, 120mg, Placebo
- Keywords
- Sexual abuse, Propranolol
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol, 120mgDrug
The experimental group will receive propranolol administered orally at a total daily dose of 120 mg, divided into three daily doses of 40 mg for 10 days, followed by a tapering phase consisting of two daily doses of 40 mg for 7 days, and then a single daily dose of 40 mg per day for an additional 7 days.
PlaceboDrug
The control group will receive a placebo in the form of capsules identical in appearance to the active treatment and administered according to the same dosing regimen as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol, 120mg | Experimental | Not described Receives: Drug: Propranolol, 120mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant rate with post-traumatic stress disorder symptoms.
Assessed using the CAPS-5 scale (Clinician Administered PTSD Scale for Diagnostic and Statistical manual of mental disorders - Fifth edition)
The diagnosis of post-traumatic stress disorder (PTSD) will be defined in the presence of:
- At least 1 item from the intrusive symptoms (cluster B)
- At least 1 item from the avoidance symptoms (cluster C)
- At least 2 items from the cognitive and mood symptoms (cluster D)
- At least 2 items from the arousal and reactivity symptoms (cluster E). In addition, the total score for clusters B + C + D + E must be at least 20 points. The severity of PTSD (post-traumatic stress disorder) is assessed by adding up the scores for the 20 post-traumatic symptoms and dividing the total by 20.
Measured: 5 weeks
Secondary outcomes (11)
Post-traumatic symptoms
Assessed using a semi-structured diagnostic interview administered by a clinician :
CAPS-5 : Clinician Administered PTSD (post-traumatic stress disorder) Scale for the Diagnostic And Statistical Manual of Mental Disorders -Fifth edition
Measured: 5-weeks
Post-traumatic and depressive symptoms
Assessed using PCL-5 (Posttraumatic Stress Disorder Checklist for Diagnostic And Statistical Manual of Mental Disorders -Fifth edition)
Measured: at 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using IES-R questionnaire (Impact of Event Scale - Revised)
Measured: 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using PHQ-9 questionnaire (Patient Health Questionnaire)
Measured: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using FAST questionnaire (Functional Assessment Staging Tool)
Measured: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using GAF questionnaire (Global Assessment of Functioning)
Measured: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using VAS scale (Visual Analog Scale of Health Status)
Measured: 5-weeks, 3-months and 6-months
Costs associated with healthcare consumption
Measured: Since Day 0 to 6-Months
Sick leave
Measured: Since Day 0 to 6-Months
Suicide risk
Assessed using C-SSRS (colombia - Suicide severity rating scale)
Measured: At 5-weeks, 3-months and 6-months
Recording of adverse events
Measured: From Day 0 to the end of the follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion6 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Matmut Paul Bennetot
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452978
- Sponsor's protocol ID
- DR230070 - PPRESVISE
- Other IDs
- 2023-504075-25-00, 2023
- Acronym
- PPRESVISE
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence: A Single-Center Randomized Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07452978
- Acronym / sponsor ID
- PPRESVISE / DR230070 - PPRESVISE
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- Sexual abuse, Propranolol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Fondation Matmut Paul Bennetot
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- 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.
The goal of this clinical trial is to evaluate the effect of early propranolol administration on the occurrence of post-traumatic stress disorder (PTSD) symptoms at five weeks in adult female victims of sexual violence.
The investigators hypothesize that propranolol administration may reduce the traumatic emotional experience associated with the memory by positively modulating neurovegetative symptoms during the memory reconsolidation phase, thereby decreasing the risk of developing post-traumatic stress disorder (PTSD). This specific context of sexual violence appears particularly suitable, given the timeline of events, to evaluate the pharmacological efficacy of propranolol on memory reconsolidation and the prevention of post-traumatic symptom development.
Participants will :
- take Propranolol, 120mg per day divided into 3 daily doses of 40mg or a placebo for 10 days, followed by a tapering phase consisting of two daily doses of 40 mg for 7 days, and then a single daily dose of 40 mg for an additional 7 days.
- Complete questionnaires
- Complete a patient follow-up diary documenting information related to the occurrence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol, 120mg | Experimental | Drug: Propranolol, 120mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- female, cisgender
- >= 18 years
- The patient agrees to comply with the contraception requirements detailed in the protocol.
- SBP > 10 cmHg
- Heart rate >= 55 bpm
Key exclusion criteria (18 listed)
- Protected adult (guardianship, curatorship, judicial protection)
- Repeated or chronic sexual violence
- Impaired consciousness or alertness, amnesia regarding events
- Known hypersensitivity to propranolol or treated asthma, even if only occasional
- Known interactions with Propranolol (combinations not recommended and combinations to be used with caution) indicated in the summary of product characteristics
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 |
|---|---|---|
| Propranolol, 120mgThe experimental group will receive propranolol administered orally at a total daily dose of 120 mg, divided into three daily doses of 40 mg for 10 days, followed by a tapering phase consisting of two daily doses of 40 mg for 7 days, and then a single daily dose of 40 mg per day for an additional 7 days. | Drug | Propranolol, 120mg |
| PlaceboThe control group will receive a placebo in the form of capsules identical in appearance to the active treatment and administered according to the same dosing regimen as the experimental group. | Drug | Placebo |
Primary outcome
Participant rate with post-traumatic stress disorder symptoms.
Time frame: 5 weeks
Assessed using the CAPS-5 scale (Clinician Administered PTSD Scale for Diagnostic and Statistical manual of mental disorders - Fifth edition) The diagnosis of post-traumatic stress disorder (PTSD) will be defined in the presence of: * At least 1 item from the intrusive symptoms (cluster B) * At least 1 item from the avoidance symptoms (cluster C) * At least 2 items from the cognitive and mood symptoms (cluster D) * At least 2 items from the arousal and reactivity symptoms (cluster E). In addition, the total score for clusters B + C + D + E must be at least 20 points. The severity of PTSD (post-traumatic stress disorder) is assessed by adding up the scores for the 20 post-traumatic symptoms and dividing the total by 20.
11 secondary outcomes
Post-traumatic symptoms
Time frame: 5-weeks
Post-traumatic and depressive symptoms
Time frame: at 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Time frame: 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Time frame: 5-weeks, 3-months and 6-months
Costs associated with healthcare consumption
Time frame: Since Day 0 to 6-Months
Sick leave
Time frame: Since Day 0 to 6-Months
Suicide risk
Time frame: At 5-weeks, 3-months and 6-months
Recording of adverse events
Time frame: From Day 0 to the end of the follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol, 120mg in people with PTSD - Post Traumatic Stress Disorder, run by University Hospital, Tours.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wissam EL HAGE, Pr. (02 47 47 71 11, W.ELHAGE@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant rate with post-traumatic stress disorder symptoms. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.