Not Yet RecruitingPhase 2

Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence

34 participantsStarted 2026-09-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Affiliated with a social security system * Patient who understands and reads french * Free, informed, and written consent signed by the participant Exclusion Criteria: * 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 * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant rate with post-traumatic stress disorder symptoms.

Timeframe: 5 weeks

Trial details

NCT IDNCT07452978

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-06

Contact for this trial

Wissam EL HAGE, Pr.

02 47 47 71 11 W.ELHAGE@chu-tours.fr

View on ClinicalTrials.gov More PTSD - Post Traumatic Stress Disorder trials