Treatment of pediatric Post-traumatic Stress Disorder with memory reactivation under the influence of propranolol: A randomized placebo-controlled trial - PPP

CHU Toulouse0 个研究点目标入组 92 人开始时间: 2021年1月22日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•-Children aged 7-12 years
•-CPTS-RI total score =40
•-Primary diagnosis of PTSD (6 months or more after the traumatic event)
•-Affiliation to a social security scheme
•-Written consent signed by the parents/holders of parental authority and the investigator
•-Acceptance of the protocol by the child
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 92
•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

•-Age<7 years or =13 years
•-Child or parents that don’t have a good understanding of the French language according to investigator's opinion
•- Children whose parents have been deprived of their authority
•-Contraindication to propranolol (cardiogenic shock, sinus bradycardia, hypotension (< fifth percentile oscillometric or <2SD) (Banker et al., 2016)., greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
•-Heart Rate/HR<50 bpm
•-Concurrent medication with possible interactions with propranolol
•--Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD
•-Concurrent psychotherapy (>1 stuctured session/month declared by the clinician who follows the child)
•-Current active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, attention-deficit hyperactivity disorder, autism spectrum disorder
•-Pregnancy

发起方

CHU Toulouse