Impact of a working method on traumatic memory under PROPRanolol in ADOlescents with post-traumatic stress syndrome (PROPRADO)

Phase 1

• Conditions: post-traumatic stress disorder; MedDRA version: 21.1Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-001878-29-FR
• Lead Sponsor: Rennes University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-23
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

- Adolescents aged 12 to 18 years;
- Exposed to a single traumatic event or to events circumscribed in time;
- Fluent in French ;
- Positive diagnosis of PTSD (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 adolescents;
- Adolescents affiliated, via their parents, to the French social security body.

Are the trial subjects under 18? yes
Number of subjects for this age range: 74
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Medical condition contraindicating administration of propranolol, such as asthma, diabetes, arrhythmia or drugs interfering with the metabolism of propranolol;
- Schizophrenia;
- Mental retardation;
- Autism spectrum disorder;
- Acute 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 (according to the Summary of Product Characteristics);
- Currently treated with a bradycardic drug;
- Concurrent psychotropic medication - with the exception of cyamemazine and hydroxyzine;
- Concurrent psychotherapy;
- Pregnancy or breast feeding.
- Concurrent participation to another interventional study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified