2025-523107-30-01招募中3 期
Women victims of violences : PTSD treatment by traumatic memory reactivation under the influence of propranolol (VIOFEM)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Pr Philippe BIRMES
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (2)
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