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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
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.
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.
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.
Time frame: 5 weeks
Post-traumatic symptoms
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
Time frame: 5-weeks
Post-traumatic and depressive symptoms
Assessed using PCL-5 (Posttraumatic Stress Disorder Checklist for Diagnostic And Statistical Manual of Mental Disorders -Fifth edition)
Time frame: at 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using IES-R questionnaire (Impact of Event Scale - Revised)
Time frame: 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using PHQ-9 questionnaire (Patient Health Questionnaire)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using FAST questionnaire (Functional Assessment Staging Tool)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using GAF questionnaire (Global Assessment of Functioning)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using VAS scale (Visual Analog Scale of Health Status)
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
Assessed using C-SSRS (colombia - Suicide severity rating scale)
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
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