The efficacy of traumatic memory modification using a memory reconsolidation procedure under propranolol among adolescents with post-traumatic stress disorder (PROPRADO) - PROPRADO

Rennes University Hospital0 个研究点目标入组 74 人开始时间: 2020年11月23日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- Adolescents aged 12 to 18 years;
•- Exposed to a single traumatic event or to events circumscribed in time;
•- Fluent in French ;
•- Positive diagnosis of PTSD (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 adolescents;
•- Adolescents affiliated, via their parents, to the French social security body.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 74
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Medical condition contraindicating administration of propranolol, such as asthma, diabetes, arrhythmia or drugs interfering with the metabolism of propranolol;
•- Schizophrenia;
•- Mental retardation;
•- Autism spectrum disorder;
•- Acute 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 (according to the Summary of Product Characteristics);
•- Currently treated with a bradycardic drug;
•- Concurrent psychotropic medication - with the exception of cyamemazine and hydroxyzine;
•- Concurrent psychotherapy;
•- Pregnancy or breast feeding.
•- Concurrent participation to another interventional study

发起方

Rennes University Hospital