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

NCT04921982 | Withdrawn Phase 2 DMC

• 1 other identifier: 35RC18_8852_PROPRADO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change on score of PCL-5

  Difference on score on the PTSD Checklist for DSM-5 (PCL-5) between inclusion and one week after the end of treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017)

  7 weeks

Secondary Outcomes (11)

• Change on score of PCL-5 after each treatment session

  6 weeks

• Change on score of PCL-5 at 3 months

  3 months

• Change on score of PCL-5 at 6 months

  6 months

• Change on score of PCL-5 at 12 months

  12 months

• Change in CPC-DSM5 questionnaire score

  12 months

Study Arms (2)

Propranolol

EXPERIMENTAL

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Propranolol 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.

Propranolol

Placebo 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.

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (10)

CHU Angers

Angers, France

Location

CHU Besançon

Besançon, France

Location

CH Bohars

Bohars, France

Location

AP-HP Louis Mourier

Colombes, France

Location

CH Le Havre

Le Havre, France

Location

CHU Limoges

Limoges, France

Location

CHU Nantes

Nantes, France

Location

CHU Poitiers

Poitiers, France

Location

CH Guillaume Régnier

Rennes, 35000, France

Location

CHU Rouen

Rouen, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jacques Dayan, Pr

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)