EUCTR2021-000312-36-FR招募中1 期
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome - PTSD-FMS
Henri Laborit Hospital0 个研究点目标入组 25 人开始时间: 2021年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Adult over 18 years old
- •- Diagnosis of fibromyalgia syndrome according to ACR 2016 criteria
- •-PCL-5 > 44 suggesting the presence of a comorbid post-traumatic stress disorder
- •-Meet the DSM-5 criteria for post-traumatic stress disorder secondary to exposure to a traumatic event according to DSM-5 criteria, both unique or repeated and regardless of the date or location of the traumatic event.
- •-Pain relief treatment and/or psychotropic treatment stabilized for a period greater than or equal to two months.
- •-Signature of a consent form
- •-Patient able to understand and read french
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Psychotic disorders
- •-Unstable bipolar disorder
- •-Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as established during the initial visit
- •-Significant anormal ECG
- •-Medical contraindication to taking propranolol
- •-Adverse reactions or previous intolerances to a beta blocker
- •-Current intake of another beta blocker which can not be stopped during the protocol, regardeless the galenic.
- •-Current intake of a drug with potential contraindication with the propranolol, according to the summary of product characteristics of the propranolol.
- •-Patient under legal protection, under guardianship or under curatorship
- •-Patient having suffered a head trauma for less than a year or with clinical symptoms and neurological sequelae
- •-Known severe suicide risk (MINI-S and medical exam)
- •-Current opioid addiction or alcohol dependence
- •-Patients treated for less than 2 months with antidepressants or painkillers
- •-Patients unafiliated to a social health care
- •-Woman who is pregnant or breast-feeding or whithout efficient contraception
研究者
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