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

Sponsor
University Hospital, Tours
Study ID
NCT07452978
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Propranolol, 120mg — DRUG
    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.
  • Placebo — DRUG
    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 Details

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.

Key Dates

First listed
Mar 5, 2026
Start date
Sep 1, 2026
Status verified
Feb 2026
Primary completion
Oct 6, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Propranolol, 120mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Participant rate with post-traumatic stress disorder symptoms. [ Time Frame: 5 weeks ]

Central Contacts

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