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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Propranolol, 120mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amélie DELAGE; Phone Number: 0247473933; Email: a.delage@chu-tours.fr
• Study Contact Backup: Name: Wissam EL HAGE, Pr.; Phone Number: 02 47 47 71 11; Email: W.ELHAGE@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Experimental: Propranolol, 120mg	Drug: Propranolol, 120mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	at 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms	Assessed using IES-R questionnaire (Impact of Event Scale - Revised)	5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms	Assessed using PHQ-9 questionnaire (Patient Health Questionnaire)	5-weeks, 3-months and 6-months
Impact on individual performance	Assessed using FAST questionnaire (Functional Assessment Staging Tool)	5-weeks, 3-months and 6-months
Impact on individual performance	Assessed using GAF questionnaire (Global Assessment of Functioning)	5-weeks, 3-months and 6-months
Impact on individual performance	Assessed using VAS scale (Visual Analog Scale of Health Status)	5-weeks, 3-months and 6-months
Costs associated with healthcare consumption		Since Day 0 to 6-Months
Sick leave		Since Day 0 to 6-Months
Suicide risk	Assessed using C-SSRS (colombia - Suicide severity rating scale)	At 5-weeks, 3-months and 6-months
Recording of adverse events		From Day 0 to the end of the follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Fondation Matmut Paul Bennetot

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Propranolol; Sexual abuse
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Combat Disorders; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amines; Alcohols; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols; Propranolol
• Other Study ID Numbers: DR230070 - PPRESVISE; 2023-504075-25-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No