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

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.

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.