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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

Qualifiers

female, cisgender

>= 18 years

The patient agrees to comply with the contraception requirements detailed in the protocol.

SBP > 10 cmHg

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Propranolol, 120mg
  • Placebo

Treatment groups

34 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University Hospital, Tours

Lead sponsor

Fondation Matmut Paul Bennetot

Collaborator