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Women victims of violences : PTSD treatment by traumatic memory reactivation under the influence of propranolol (VIOFEM)
EU CTIS ID: 2025-523107-30-01
What this study is testing
To evaluate, in a group of women who are victims of violence and suffer from PTSD, the effect of treatment consisting of 6 sessions (1 per week) of traumatic memory reactivation under propranolol/PPNL (a single dose of propranolol administered prior to the traumatic memory reactivation) compared to the effect of treatment with 8 sessions (1 per week) of prolonged exposure psychotherapy (EP) on PTSD symptoms.
- Therapeutic confirmatory (Phase III)
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
- Women aged from 18 to 75 years
- Having been victim of severe violence (rape, sexual assault, physical assault)
- Currently suffering from PTSD related to the traumatic event. The diagnosis of PTSD is made according to the DSM-5 criteria by a psychiatrist/psychologist using the CAPS-5, regardless of the traumatic event meeting criterion A of the DSM-5, with or without dissociative symptoms as described in the “With dissociative symptoms” section of the DSM-5, Immediate or delayed PTSD
- heart rate ≥ 55 bpm
- The subject must have signed the consent form.
- The subject must be enrolled in a social security program.
You likely can't join if
- Systolic blood pressure below 100 mm Hg.
- Patients who have suffered a head injury within the past year or who have clinical symptoms and residual neurological sequelae
- Wearing contact lenses
- Hospitalized or treated for suicidal behavior within the past 3 months
- Previous intolerance to a beta-blocker.
- Women of childbearing age not using contraception
See the full eligibility criteria
- Women aged from 18 to 75 years
- Having been victim of severe violence (rape, sexual assault, physical assault)
- Currently suffering from PTSD related to the traumatic event. The diagnosis of PTSD is made according to the DSM-5 criteria by a psychiatrist/psychologist using the CAPS-5, regardless of the traumatic event meeting criterion A of the DSM-5, with or without dissociative symptoms as described in the “With dissociative symptoms” section of the DSM-5, Immediate or delayed PTSD
- heart rate ≥ 55 bpm
- The subject must have signed the consent form.
- The subject must be enrolled in a social security program.
- The participant must be able to understand and read French.
- The participant agrees to comply with the contraception requirements outlined in the protocol
- CAPS-5 total score ≥ 33
- Systolic blood pressure below 100 mm Hg.
- Patients who have suffered a head injury within the past year or who have clinical symptoms and residual neurological sequelae
- Wearing contact lenses
- Hospitalized or treated for suicidal behavior within the past 3 months
- Previous intolerance to a beta-blocker.
- Women of childbearing age not using contraception
- Pregnancy, breastfeeding
- Current use of a beta-blocker, regardless of the formulation.
- Known interactions with Propranolol (combination use not recommended and combinations to be used with caution) as indicated in the summary of product characteristics
- Undergoing psychotherapy or pharmacological treatment with psychotropic agents such as antidepressants, neuroleptics, and/or mood stabilizers. However, these subjects may be included after a 2-week therapeutic abstinence period (6 weeks for treatment with fluoxetine).
- Patients under judicial protection, under guardianship or curatorship, individuals under family authorization, or under a future protection order with representation regarding the person
- USevere psychiatric disorders: Severe symptoms of other anxiety disorders, severe symptoms of Obsessive-Compulsive Disorder, history of or current psychotic disorder, bipolar mood disorder, severe personality disorder, alcohol or other substance use disorder
- Participants who are related to a person involved in the study at the investigator’s center, within the clinical research organization (CRO), or at the sponsor
- Participation in another interventional research study, clinical trial, or clinical investigation within the 6 months preceding selection
- “Yes” response to item 4 of the C-SSRS: active suicidal ideation with intent to act, without a specific plan, and/or “Yes” response to item 5 of the C-SSRS: active suicidal ideation with a specific plan and intent to act
- Propanolol contrindications
- Heart failure (compensated or decompensated)
- Severe liver disease
- Significant renal impairment
- Myasthenia gravis
- Personal or family history of psoriasis
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, 18-64 years, 65+ 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.