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NCT Number: NCT07452978

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

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.

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Combat Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Participant rate with post-traumatic stress disorder symptoms.

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. Post-traumatic symptoms

    Time frame: 5-weeks

    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

  2. Post-traumatic and depressive symptoms

    Time frame: at 5-weeks, 3-months and 6-months

    Assessed using PCL-5 (Posttraumatic Stress Disorder Checklist for Diagnostic And Statistical Manual of Mental Disorders -Fifth edition)

  3. Post-traumatic and depressive symptoms

    Time frame: 5-weeks, 3-months and 6-months

    Assessed using IES-R questionnaire (Impact of Event Scale - Revised)

  4. Post-traumatic and depressive symptoms

    Time frame: 5-weeks, 3-months and 6-months

    Assessed using PHQ-9 questionnaire (Patient Health Questionnaire)

  5. Impact on individual performance

    Time frame: 5-weeks, 3-months and 6-months

    Assessed using FAST questionnaire (Functional Assessment Staging Tool)

  6. Impact on individual performance

    Time frame: 5-weeks, 3-months and 6-months

    Assessed using GAF questionnaire (Global Assessment of Functioning)

  7. Impact on individual performance

    Time frame: 5-weeks, 3-months and 6-months

    Assessed using VAS scale (Visual Analog Scale of Health Status)

  8. Costs associated with healthcare consumption

    Time frame: Since Day 0 to 6-Months

  9. Sick leave

    Time frame: Since Day 0 to 6-Months

  10. Suicide risk

    Time frame: At 5-weeks, 3-months and 6-months

    Assessed using C-SSRS (colombia - Suicide severity rating scale)

  11. Recording of adverse events

    Time frame: From Day 0 to the end of the follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie DELAGE

CONTACT

[email protected]

0247473933

Wissam EL HAGE, Pr.

CONTACT

[email protected]

02 47 47 71 11

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Fondation Matmut Paul Bennetot

Registry information

Official study title

Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence: A Single-Center Randomized Placebo-Controlled Pilot Study

Acronym: PPRESVISE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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