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RECRUITING
NCT04985344
PHASE3

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

Official title: Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-02-01

Completion Date

2027-09

Last Updated

2023-08-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Propranolol Oral Product

Child will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance.

DRUG

Placebo

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.

OTHER

memory reactivation

90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma.

Locations (1)

Toulouse University Hospital

Toulouse, France