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

Primary Purpose

Post Traumatic Stress Disorder

Status

Not yet recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Propranolol

Placebo

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change on score of PCL-5 after each treatment session

Difference on score on the post-traumatic stress disorder Checklist for DSM-5 (PCL-5) between inclusion and after each dispensation 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) Scores consist of a total symptom severity score (from 0 to 80) Consistent with the likert scale: 0 = Not at all = A little bit = Moderately = Quite a bit = Extremely Higher scores mean a worse outcome.

Change on score of PCL-5 at 3 months

Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 3 months after the beginning of the 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) Scores consist of a total symptom severity score (from 0 to 80) Consistent with the likert scale: 0 = Not at all = A little bit = Moderately = Quite a bit = Extremely Higher scores mean a worse outcome.

Change on score of PCL-5 at 6 months

Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 6 months after the beginning of the 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) Scores consist of a total symptom severity score (from 0 to 80) Consistent with the likert scale: 0 = Not at all = A little bit = Moderately = Quite a bit = Extremely Higher scores mean a worse outcome.

Change on score of PCL-5 at 12 months

Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 12 months after the beginning of the 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) Scores consist of a total symptom severity score (from 0 to 80) Consistent with the likert scale: 0 = Not at all = A little bit = Moderately = Quite a bit = Extremely Higher scores mean a worse outcome.

Change in CPC-DSM5 questionnaire score

Difference in functional impairment score of CPC-DSM5 at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6 and 12 months after the beginning of treatment. Functional impairment score will be assessed using CHILD PTSD CHECKLIST PARENT questionnaire. CPC is a self-questionnaire of 12 items. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items. The CPSS-5-I also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items 15-20). The interviewer rates the seven impairment items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28. The total impairment score does not contribute to the overall severity score.

Change in SCID-5 questionnaire score

Difference in Categorical diagnosis of PTSD using SCID-5 questionnaire at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6 and 12 months after the beginning of treatment. SCID-5 is for Structured Clinical Interview for DSM-5 is a semi-structured interview guide for making the major DSM-5 diagnoses used for the diagnosis of PTSD and depression.

Change in Child Depression Inventory score

Difference in Child Depression Inventory (CDI) score between inclusion visit and one week after the end of treatment, 6 months and 12 months after the beginning of treatment. There are 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; children and adolescents select the one that characterized their symptoms best during the past 2 weeks. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.

Change in Adolescent Dissociative Experience scale

Difference in Adolescent Dissociative Experience (DES-A) score at inclusion visit, one week after the end of treatment, 6 and 12 months after the beginning of treatment. DES-A is a 28-items selfquestionnaire. Each item reaches to 0 (never happening) to 10 (always happening)

Change in Youth Self Report score

Scores for Behavioral and Somatic Disorders and for School/social functioning using Youth Self report (CBCL/YSR, parents/children) at inclusion visit , one week after the end of treatment, 6 and 12 months after the beginning of treatment. The YSR is a 112-item self-report designed for children and adolescents (ages 11-17) and largely used worldwide. It assesses behavioral competency and behavioral problems and parallels the Child Behavior Checklist (CBCL). The questionnaire provides scores for the following syndrome scales: anxious/depressed, withdrawn/depressed, somatic complains, social problems, thought problems, rule-breaking behavior, and aggressive behavior. The questionnaire provides scores for DSM-oriented scales. The YSR consists of 112 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often) Higher scores mean a worse outcome.

Change in suicidal riskk using Mini-Kid questionnaire

Difference in acute suicidal risk using Mini Kid questionnaire at inclusion visit , one week after the end of treatment, 6 and 12 months after the beginning of treatment. The Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) is a short, structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders in children and adolescents. Only part C will be used to assess diagnosis of acute suicidal risk. Scores reaches from 0 to 10 Higher scores mean a worse outcome.

Evaluation of the tolerance to treatment

Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks) by the research nurse: Clinical evaluation

Full Information

NCT ID

NCT04921982

First Posted

June 4, 2021

Last Updated

November 29, 2022

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04921982

Brief Title

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

Acronym

PROPRADO

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propranolol

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Propranolol

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention 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.

Primary Outcome Measure Information:

Title

Change on score of PCL-5

Description

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Change on score of PCL-5 after each treatment session

Description

Time Frame

6 weeks

Title

Change on score of PCL-5 at 3 months

Description

Time Frame

3 months

Title

Change on score of PCL-5 at 6 months

Description

Time Frame

6 months

Title

Change on score of PCL-5 at 12 months

Description

Time Frame

12 months

Title

Change in CPC-DSM5 questionnaire score

Description

Time Frame

12 months

Title

Change in SCID-5 questionnaire score

Description

Time Frame

12 months

Title

Change in Child Depression Inventory score

Description

Time Frame

12 months

Title

Change in Adolescent Dissociative Experience scale

Description

Time Frame

12 months

Title

Change in Youth Self Report score

Description

Time Frame

12 months

Title

Change in suicidal riskk using Mini-Kid questionnaire

Description

Time Frame

12 months

Title

Evaluation of the tolerance to treatment

Description

Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks) by the research nurse: Clinical evaluation

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jacques Dayan, Pr

Phone

299284321

Ext

+33

jacques.dayan@chu-rennes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Dayan, Pr

Organizational Affiliation

CHU Rennes

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Angers

City

Angers

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elise Riquin, Md

First Name & Middle Initial & Last Name & Degree

Elise Riquin

Facility Name

CHU Besançon

City

Besançon

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauriane Vuilliez, Md

First Name & Middle Initial & Last Name & Degree

Lauriane Vuilliez, Md

Facility Name

CH Bohars

City

Bohars

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Bronsard

First Name & Middle Initial & Last Name & Degree

Guillaume Bronsard, Pr

Facility Name

AP-HP Louis Mourier

City

Colombes

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline Dubertret, Pr

First Name & Middle Initial & Last Name & Degree

Caroline Dubertret, Pr

Facility Name

CH Le Havre

City

Le Havre

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gisele Apter

First Name & Middle Initial & Last Name & Degree

Gisele Apter, Pr

Facility Name

CHU Limoges

City

Limoges

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertrand Olliac

First Name & Middle Initial & Last Name & Degree

Bertrand Olliac, Pr

Facility Name

CHU Nantes

City

Nantes

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Bonnot

First Name & Middle Initial & Last Name & Degree

Olivier Bonnot, Pr

Facility Name

CHU Poitiers

City

Poitiers

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ludovic Gicquel

First Name & Middle Initial & Last Name & Degree

Ludovic Gicquel, Pr

Facility Name

CH Guillaume Régnier

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacques Dayan, Pr

jacques.dayan@chu-rennes.fr

First Name & Middle Initial & Last Name & Degree

Jacques Dayan

Facility Name

CHU Rouen

City

Rouen

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Priscille GERARDIN

First Name & Middle Initial & Last Name & Degree

Priscille GERARDIN, Pr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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

Post Traumatic Stress Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial