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

Who is this study for? Patients with Posttraumatic Stress Disorder
What treatments are being studied? Memory Reactivation
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Toulouse University Hospital
RECRUITING
Toulouse
Contact Information
Primary
Philippe Birmes, PH
birmes.p@chu-toulouse.fr
05 34 55 75 00
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 92
Treatments
Experimental: Propranolol
Patient will receive oral propranolol
Placebo_comparator: Placebo
Patient will receive oral placebo
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov

Similar Clinical Trials