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

Phase 1

• Conditions: Post-traumatic Stress Disorder; MedDRA version: 20.0Level: HLTClassification code 10042211Term: Stress disordersSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-005956-39-FR
• Lead Sponsor: CHU Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified