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Propranolol for early secondary prevention of post-traumatic stress disorder in female victims of sexual violence: a single-center, randomized, placebo-controlled pilot study - PPRESVISE
EU CTIS ID: 2023-504075-25-00
What this study is testing
Évaluer l’effet de la prise précoce du Propranolol sur la survenue des symptômes du TSPT à cinq semaines chez les femmes majeures victimes de violences sexuelles.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Femme (sexe féminin, cisgenre)
- Heart rate ≥ 55 bpm
- Patient understanding and reading French
- Âge supérieur ou égal à 18 ans
- Patient agrees to follow contraceptive requirements detailed in protocol
- PAS supérieur à 10 cm Hg
You likely can't join if
- Majeure protégée (tutelle, curatelle, sauvegarde de justice)
- Conscience ou vigilance perturbée, amnésie des faits
- Patients with severe liver disease and/or significant renal insufficiency
- Hypersensibilité connue au Propranolol ou asthme traité, même de façon occasionnelle
- Prise actuelle d’un bêta-bloquant quelle que soit la galénique
- Patients with myasthenia gravis and a personal history of psoriasis
See the full eligibility criteria
- Femme (sexe féminin, cisgenre)
- Heart rate ≥ 55 bpm
- Patient understanding and reading French
- Âge supérieur ou égal à 18 ans
- Patient agrees to follow contraceptive requirements detailed in protocol
- PAS supérieur à 10 cm Hg
- Reçue en consultation de violences sexuelles dans l’Unité Médico-Judiciaire (UMJ) pour attouchements et/ou viol dans les 72h après la survenue des faits
- Affiliée à un régime de sécurité sociale
- Consentement libre, éclairé et écrit signé par la participante
- Patient agrees to follow contraceptive requirements detailed in protocol
- Majeure protégée (tutelle, curatelle, sauvegarde de justice)
- Conscience ou vigilance perturbée, amnésie des faits
- Patients with severe liver disease and/or significant renal insufficiency
- Hypersensibilité connue au Propranolol ou asthme traité, même de façon occasionnelle
- Prise actuelle d’un bêta-bloquant quelle que soit la galénique
- Patients with myasthenia gravis and a personal history of psoriasis
- Known interactions with Propranolol (associations not recommended and associations to be used with caution) indicated in the summary of product characteristics (Appendix 11)
- Patients wearing contact lenses
- People currently receiving psychotropic treatment such as antipsychotics or antidepressants.
- People with known serious psychiatric disorders, current or past
- Prise actuelle d’un médicament présentant une interaction médicamenteuse contre-indiquée ou déconseillée avec le Propranolol : Bepridil, Diltiazem, Verapamil, Fingolimod.
- Addiction : présence d’un trouble actuel lié à l’usage de substances psychoactives
- Traitement par benzodiazépines en cours
- Patients with head trauma within the last year or with clinical symptoms and neurological sequelae
- High suicide risk, i.e., in 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 preceding selection.
- Femme enceinte ou allaitante
- Patient previously diagnosed with PTSD
- Violences sexuelles répétées ou chroniques
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.