NCT04985344 Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 92 participants in total. It began in 2023-02-01 with a primary completion date of 2027-09.

Brief Summary

By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out. The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory. Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.

Eligibility Criteria

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

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