Actively Recruiting

Phase 3
Age: 7Years - 12Years
All Genders
NCT04985344

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

Led by University Hospital, Toulouse · Updated on 2023-08-28

92

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 7-12 years
  • CPTS-RI total score 60
  • Primary diagnosis of PTSD (6 months or more after the traumatic event)
  • Heart rate 65 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
Not Eligible

You will not qualify if you...

  • Age under 7 years or 13 years and older
  • Children whose parents have been deprived of their authority
  • Contraindication to propranolol (cardiogenic shock, sinus bradycardia, hypotension, greater than first-degree heart block, heart failure, bronchial asthma, hypersensitivity to propranolol hydrochloride)
  • Concurrent medication with possible interactions with propranolol
  • Concurrent psychotropic drugs effective in improving PTSD symptoms (antidepressants, atypical antipsychotics, mood stabilizers)
  • Concurrent psychotherapy (more than 1 structured session per month)
  • 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 more than 10 minutes)
  • Currently treated with a bradycardic drug
  • Concurrent participation in another interventional study
  • Renal or hepatic impairment
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Toulouse University Hospital

Toulouse, France, 31059

Actively Recruiting

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Research Team

P

Philippe Birmes, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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