PTSD - Post Traumatic Stress Disorder
Conditions
Keywords
Sexual abuse, Propranolol
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.
Interventions
DRUGPropranolol, 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.
DRUGPlacebo
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.
Sponsors
University Hospital, Tours
Fondation Matmut Paul Bennetot
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant rate with post-traumatic stress disorder symptoms. | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic symptoms | 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 |
| Post-traumatic and depressive symptoms | 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) |
| Impact on individual performance | 5-weeks, 3-months and 6-months | Assessed using FAST questionnaire (Functional Assessment Staging Tool) |
| Costs associated with healthcare consumption | Since Day 0 to 6-Months | — |
| Sick leave | Since Day 0 to 6-Months | — |
| Suicide risk | At 5-weeks, 3-months and 6-months | Assessed using C-SSRS (colombia - Suicide severity rating scale) |
| Recording of adverse events | From Day 0 to the end of the follow-up | — |
Contacts
CONTACTWissam EL HAGE, Pr.
CONTACTAmélie DELAGE
Outcome results
None listed