Treating pediatric PTSD with memory reactivation and propranolol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of propranolol, a beta-blocker, in conjunction with memory reactivation techniques to treat pediatric post-traumatic stress disorder (PTSD) in children aged 7-12. The study aims to disrupt the reconsolidation of traumatic memories, potentially reducing the emotional impact of these memories. Participants will receive either propranolol or a placebo while undergoing memory reactivation sessions. The trial seeks to provide a novel approach to treating PTSD in children, where traditional therapies may lead to high dropout rates due to the intensity of re-experiencing trauma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 7-12 years
* CPTS-RI total score ≥40
* Primary diagnosis of PTSD (6 months or more after the traumatic event)
* Heart rate ≥ 55 bpm
* Systolic blood pressure ≥ 95 mm Hg
* 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-Child and Parents/Holders of parental authority fluent in French

Exclusion Criteria:

* Age\<7 years or ≥13 years
* 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 - see APPENDIX 1), greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
* Concurrent medication with possible interactions with propranolol (cf 8.2)
* Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD (Antidepressants, atypical antipsychotics, mood stabilizers)
* Concurrent psychotherapy (\>1 structured 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
* Children with psoriasis
* Children with a predisposition to hypoglycemia
* Obsessive-compulsive disorders
* Bipolar Disorders
* Mental retardation,
* Traumatic brain injury (loss of consciousness \> 10 minutes)
* Currently treated with a bradycardic drug
* Concurrent participation to another interventional study
* Renal or Hepatic Impairment
* Pregnancy

Where it's running

• Toulouse University Hospital
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Philippe Birmes, PH — University Hospital, Toulouse
• Study coordinator: Philippe Birmes, PH
• Email: birmes.p@chu-toulouse.fr
• Phone: 05 34 55 75 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.