Efficacy of Traumatic Memory Modification Using Memory Reconsolidation and Propranolol Among Adolescents With PTSD (PROPRADO)

Rennes University Hospital

Status and phase

Withdrawn

Phase 2

Conditions

Post Traumatic Stress Disorder

Treatments

Drug: Propranolol

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04921982

35RC18_8852_PROPRADO

Details and patient eligibility

About

The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- Adolescents aged 12 to 18 years;
Exposed to a single traumatic event or to events circumscribed in time, including sexual abuse in the absence of reminders in the environment;
Fluent in French;
Positive diagnosis of PTSD with the SCID-5;
Disorders evolving for at least three months;
Heart rate ≥ 55 bpm;
Systolic blood pressure ≥ 100 mmHg;
Written parental or legal guardian consent;
Written agreement by the adolescent;
Adolescents affiliated, via their parents, to the French social security body.

Exclusion criteria

- Medical condition contraindicating administration of propranolol (COPD, asthma, cardio-vascular insufficiency, heart failure as second- and third-degree atrioventricular blocks, Prinzmetal angor, pheochromocytoma, Raynaud disease, history of an anaphylactic reaction, sinus node disease, hypoglycemia, AV blocks)
Known chronic renal or hepatic insufficiency
Schizophrenia;
Mental retardation;
Autism spectrum disorder;
Acute severe suicidal ideation
Traumatic brain injury (loss of consciousness > 10 minutes);
Currently treated for substance or alcohol dependence;
Currently treated for Attention Deficit Hyperactivity Disorder;
Currently treated with a drug that can interfere with propranolol and that can represent a danger according to medical advice if it's suspended more than 24 hours.
Currently treated with a bradycardic drug;
Concurrent psychotropic medication with the exception of cyamemazine (suspended 48 hours before session)
Concurrent trauma-focused psychotherapy in progress or stopped less than 1 month ago;
Pregnancy or breast feeding.
Current use of "recreative" toxic drugs
Concurrent participation to another interventional study