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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504075-25-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Fondation Matmut Paul Bennetot | UNKNOWN |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol, 120mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5-weeks |
| Post-traumatic and depressive symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Woman (female, cisgender)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wissam EL HAGE, Pr. | Contact | 02 47 47 71 11 | W.ELHAGE@chu-tours.fr | |
| Amélie DELAGE | Contact | 0247473933 | a.delage@chu-tours.fr |
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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.
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| 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. |
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Assessed using PCL-5 (Posttraumatic Stress Disorder Checklist for Diagnostic And Statistical Manual of Mental Disorders -Fifth edition) |
| at 5-weeks, 3-months and 6-months |
| Post-traumatic and depressive symptoms | Assessed using IES-R questionnaire (Impact of Event Scale - Revised) | 5-weeks, 3-months and 6-months |
| Post-traumatic and depressive symptoms | Assessed using PHQ-9 questionnaire (Patient Health Questionnaire) | 5-weeks, 3-months and 6-months |
| Impact on individual performance | Assessed using FAST questionnaire (Functional Assessment Staging Tool) | 5-weeks, 3-months and 6-months |
| Impact on individual performance | Assessed using GAF questionnaire (Global Assessment of Functioning) | 5-weeks, 3-months and 6-months |
| Impact on individual performance | Assessed using VAS scale (Visual Analog Scale of Health Status) | 5-weeks, 3-months and 6-months |
| Costs associated with healthcare consumption | Since Day 0 to 6-Months |
| Sick leave | Since Day 0 to 6-Months |
| Suicide risk | Assessed using C-SSRS (colombia - Suicide severity rating scale) | At 5-weeks, 3-months and 6-months |
| Recording of adverse events | From Day 0 to the end of the follow-up |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |