RecruitingPhase 3NCT04985344

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


Sponsor

University Hospital, Toulouse

Enrollment

92 participants

Start Date

Feb 1, 2023

Study Type

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

Min Age: 7 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a novel treatment approach for children with post-traumatic stress disorder (PTSD): using propranolol (a heart medication) during a specific memory recall session, with the aim of weakening the emotional power of traumatic memories. This approach is called memory reactivation under propranolol. **You may be eligible if...** - Your child is between 7 and 12 years old - Your child has a diagnosis of PTSD, at least 6 months after the traumatic event - Your child's PTSD symptoms score high on the CPTS-RI scale (≥40) - Your child has a normal resting heart rate and blood pressure - Both parents/guardians and the child speak French **You may NOT be eligible if...** - Your child is outside the age range (younger than 7 or 13 or older) - Your child has a medical condition that makes propranolol unsafe (e.g., heart problems, asthma, low blood pressure) - Your child is currently in psychotherapy or taking psychiatric medications - Your child has another active psychiatric diagnosis (e.g., psychosis, ADHD, bipolar disorder, autism) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropranolol 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.

DRUGPlacebo

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.

OTHERmemory 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

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NCT04985344


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