NCT04921982撤回2 期
The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder
Rennes University Hospital10 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 74
- 试验地点
- 10
- 主要终点
- Change on score of PCL-5
研究概览
简要总结
The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adolescents aged 12 to 18 years;
- •Exposed to a single traumatic event or to events circumscribed in time, including sexual abuse in the absence of reminders in the environment;
- •Fluent in French;
- •Positive diagnosis of PTSD with the SCID-5;
- •Disorders evolving for at least three months;
- •Heart rate ≥ 55 bpm;
- •Systolic blood pressure ≥ 100 mmHg;
- •Written parental or legal guardian consent;
- •Written agreement by the adolescent;
- •Adolescents affiliated, via their parents, to the French social security body.
排除标准
- •- Medical condition contraindicating administration of propranolol (COPD, asthma, cardio-vascular insufficiency, heart failure as second- and third-degree atrioventricular blocks, Prinzmetal angor, pheochromocytoma, Raynaud disease, history of an anaphylactic reaction, sinus node disease, hypoglycemia, AV blocks)
- •Known chronic renal or hepatic insufficiency
- •Schizophrenia;
- •Mental retardation;
- •Autism spectrum disorder;
- •Acute severe suicidal ideation
- •Traumatic brain injury (loss of consciousness > 10 minutes);
- •Currently treated for substance or alcohol dependence;
- •Currently treated for Attention Deficit Hyperactivity Disorder;
- •Currently treated with a drug that can interfere with propranolol and that can represent a danger according to medical advice if it's suspended more than 24 hours.
- •Currently treated with a bradycardic drug;
- •Concurrent psychotropic medication with the exception of cyamemazine (suspended 48 hours before session)
- •Concurrent trauma-focused psychotherapy in progress or stopped less than 1 month ago;
- •Pregnancy or breast feeding.
- •Current use of "recreative" toxic drugs
- •Concurrent participation to another interventional study
研究组 & 干预措施
Propranolol
Experimental
干预措施: Propranolol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change on score of PCL-5
时间窗: 7 weeks
Difference on score on the PTSD Checklist for DSM-5 (PCL-5) between inclusion and one week after the end of treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017)
次要结局
- Change on score of PCL-5 after each treatment session(6 weeks)
- Change on score of PCL-5 at 6 months(6 months)
- Change in SCID-5 questionnaire score(12 months)
- Change in suicidal riskk using Mini-Kid questionnaire(12 months)
- Change on score of PCL-5 at 3 months(3 months)
- Change in CPC-DSM5 questionnaire score(12 months)
- Change in Child Depression Inventory score(12 months)
- Change in Adolescent Dissociative Experience scale(12 months)
- Change on score of PCL-5 at 12 months(12 months)
- Change in Youth Self Report score(12 months)
- Evaluation of the tolerance to treatment(6 weeks)
研究者
研究点 (10)
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