Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol
Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
University Hospital, Toulouse
92 participants
Feb 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria17
- 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
Interventions
Child will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance.
Child will receive oral placebo (syrup). The dose of placebo will increase gradually over the first 3 treatment sessions in order to match propranolol intervention.
90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04985344