Clinical trial NCT04921982: Efficacy of Traumatic Memory Modification Using Memory Reconsolidation and Propranolol Among Adolescents With PTSD
Official title: The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change on score of PCL-5
timeFrame: 7 weeks
Secondary outcomes:
measure: Change on score of PCL-5 after each treatment session
timeFrame: 6 weeks
measure: Change on score of PCL-5 at 3 months
timeFrame: 3 months
measure: Change on score of PCL-5 at 6 months
timeFrame: 6 months
measure: Change on score of PCL-5 at 12 months
timeFrame: 12 months
measure: Change in CPC-DSM5 questionnaire score
timeFrame: 12 months
measure: Change in SCID-5 questionnaire score
timeFrame: 12 months
measure: Change in Child Depression Inventory score
timeFrame: 12 months
measure: Change in Adolescent Dissociative Experience scale
timeFrame: 12 months
measure: Change in Youth Self Report score
timeFrame: 12 months
measure: Change in suicidal riskk using Mini-Kid questionnaire
timeFrame: 12 months
measure: Evaluation of the tolerance to treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bohars
country: France
facility: CH Bohars
city: Colombes
country: France
facility: AP-HP Louis Mourier
city: Le Havre
country: France
facility: CH Le Havre
city: Limoges
country: France
facility: CHU Limoges
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CH Guillaume Régnier
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: CHU Rennes
name: Jacques Dayan, Pr
role: PRINCIPAL_INVESTIGATOR
References: