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Not yet recruiting NCT07452978

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

Phase II Interventional PTSD - Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propranolol, 120mg, Placebo.
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Participant rate with post-traumatic stress disorder symptoms. [Time frame: 5 weeks]
Secondary outcome measures (11)
  • Post-traumatic symptoms [Time frame: 5-weeks]
  • Post-traumatic and depressive symptoms [Time frame: at 5-weeks, 3-months and 6-months]
  • Post-traumatic and depressive symptoms [Time frame: 5-weeks, 3-months and 6-months]
  • Post-traumatic and depressive symptoms [Time frame: 5-weeks, 3-months and 6-months]
  • Impact on individual performance [Time frame: 5-weeks, 3-months and 6-months]
  • Impact on individual performance [Time frame: 5-weeks, 3-months and 6-months]
  • Impact on individual performance [Time frame: 5-weeks, 3-months and 6-months]
  • Costs associated with healthcare consumption [Time frame: Since Day 0 to 6-Months]
  • Sick leave [Time frame: Since Day 0 to 6-Months]
  • Suicide risk [Time frame: At 5-weeks, 3-months and 6-months]
  • Recording of adverse events [Time frame: From Day 0 to the end of the follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07452978 · DR230070 - PPRESVISE · 2023-504075-25-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗