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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propranolol

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Oral administration of Propranolol, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse once a week for six consecutive weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of Placebo, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse, once a week for six consecutive weeks.

Interventions

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Propranolol

Oral administration of Propranolol, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse once a week for six consecutive weeks.

Intervention Type DRUG

Placebo

Oral administration of Placebo, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse, once a week for six consecutive weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No