RECRUITINGPhase 3INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

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