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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Propranolol

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