NCT07452978

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
18mo left

Started Sep 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 23, 2026

Last Update Submit

February 27, 2026

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

Sexual abusePropranolol

Outcome Measures

Primary Outcomes (1)

  • Participant rate with post-traumatic stress disorder symptoms.

    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.

    5 weeks

Secondary Outcomes (11)

  • Post-traumatic symptoms

    5-weeks

  • Post-traumatic and depressive symptoms

    at 5-weeks, 3-months and 6-months

  • Post-traumatic and depressive symptoms

    5-weeks, 3-months and 6-months

  • Post-traumatic and depressive symptoms

    5-weeks, 3-months and 6-months

  • Impact on individual performance

    5-weeks, 3-months and 6-months

  • +6 more secondary outcomes

Study Arms (2)

Propranolol, 120mg

EXPERIMENTAL
Drug: Propranolol, 120mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Propranolol, 120mgDRUG

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.

Propranolol, 120mg
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman (female, cisgender)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Combat Disorders

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Central Study Contacts

Wissam EL HAGE, Pr.

CONTACT

02 47 47 71 11W.ELHAGE@chu-tours.fr

Amélie DELAGE

CONTACT

0247473933a.delage@chu-tours.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 5, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 6, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.