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

The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder

Sponsors

Lead Sponsor: Rennes University Hospital

Source Rennes University Hospital
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.

Overall Status Not yet recruiting
Start Date 2022-01-01
Completion Date 2026-06-01
Primary Completion Date 2025-03-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change on score of PCL-5 7 weeks
Enrollment 74
Condition
Intervention

Intervention Type: Drug

Intervention Name: Propranolol

Description: 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.

Arm Group Label: Propranolol

Intervention Type: Drug

Intervention Name: Placebo

Description: 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.

Arm Group Label: Placebo

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

Gender:

All

Minimum Age:

12 Years

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jacques Dayan, Pr Principal Investigator CHU Rennes
Overall Contact

Last Name: Jacques Dayan, Pr

Phone: 299284321

Phone Ext.: +33

Email: [email protected]

Location
Facility: Contact: Investigator:
CHU Angers | Angers, France Elise Riquin, Md Elise Riquin Principal Investigator
CHU Besançon | Besançon, France Lauriane Vuilliez, Md Lauriane Vuilliez, Md Principal Investigator
CH Bohars | Bohars, France Guillaume Bronsard Guillaume Bronsard, Pr Principal Investigator
AP-HP Louis Mourier | Colombes, France Caroline Dubertret, Pr Caroline Dubertret, Pr Principal Investigator
CH Le Havre | Le Havre, France Gisele Apter Gisele Apter, Pr Principal Investigator
CHU Limoges | Limoges, France Bertrand Olliac Bertrand Olliac, Pr Principal Investigator
CHU Nantes | Nantes, France Olivier Bonnot Olivier Bonnot, Pr Principal Investigator
CHU Poitiers | Poitiers, France Ludovic Gicquel Ludovic Gicquel, Pr Principal Investigator
CH Guillaume Régnier | Rennes, 35000, France Jacques Dayan, Pr [email protected] Jacques Dayan Principal Investigator
CHU Rouen | Rouen, France Priscille GERARDIN Priscille GERARDIN, Pr Principal Investigator
Location Countries

France

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Propranolol

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Acronym PROPRADO
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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