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

Официальное название

Propranolol for Early Secondary Prevention of Post-Traumatic Stress Disorder in Women Victims of Sexual Violence: A Single-Center Randomized Placebo-Controlled Pilot Study

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Participant rate with post-traumatic stress disorder symptoms. [Срок оценки: 5 weeks]

Вторичные конечные точки (11)

• Post-traumatic symptoms [Срок оценки: 5-weeks]
• Post-traumatic and depressive symptoms [Срок оценки: at 5-weeks, 3-months and 6-months]
• Post-traumatic and depressive symptoms [Срок оценки: 5-weeks, 3-months and 6-months]
• Post-traumatic and depressive symptoms [Срок оценки: 5-weeks, 3-months and 6-months]
• Impact on individual performance [Срок оценки: 5-weeks, 3-months and 6-months]
• Impact on individual performance [Срок оценки: 5-weeks, 3-months and 6-months]
• Impact on individual performance [Срок оценки: 5-weeks, 3-months and 6-months]
• Costs associated with healthcare consumption [Срок оценки: Since Day 0 to 6-Months]
• Sick leave [Срок оценки: Since Day 0 to 6-Months]
• Suicide risk [Срок оценки: At 5-weeks, 3-months and 6-months]
• Recording of adverse events [Срок оценки: From Day 0 to the end of the follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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