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

The efficacy of traumatic memory modification using a memory reconsolidation procedure under propranolol among adolescents with post-traumatic stress disorder (PROPRADO) - PROPRADO

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001878-29-FR

Enrollment

Registered

2020-11-23

Start date

2021-05-21

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-traumatic stress disorder MedDRA version: 21.1 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: chlorhydrate de propranolol Product Code: propranolol Pharmaceutical Form: Capsule Product Name: cellulose microcristalline Product Code: placebo Pharmaceutical Form: Capsule Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of propranolol in blocking the reconsolidation of traumatic memory in Post-Traumatic Stress Disorder (PTSD);Secondary Objective: 1) To establish the detailed symptom profile for the evolution of PTSD during treatment and short and long term after treatment; 2) To evaluate efficacy on comorbid disorders; 3) To evaluate tolerance to treatment ;Primary end point(s): Score on the PTSD Checklist for DSM-5 (PCL-5) one week after the end of treatment.;Timepoint(s) of evaluation of this end point: 7 weeks	—

Measure

Time frame

Main Objective: To evaluate the efficacy of propranolol in blocking the reconsolidation of traumatic memory in Post-Traumatic Stress Disorder (PTSD);Secondary Objective: 1) To establish the detailed symptom profile for the evolution of PTSD during treatment and short and long term after treatment; 2) To evaluate efficacy on comorbid disorders; 3) To evaluate tolerance to treatment ;Primary end point(s): Score on the PTSD Checklist for DSM-5 (PCL-5) one week after the end of treatment.;Timepoint(s) of evaluation of this end point: 7 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1) Symptomatic evolution of PTSD - PCL5 at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment, and 3, 6, 12 months after the beginning of treatment. - Functional impairment score (CPC- DSM5, Scheerringa) at the inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6, 12 months after the beginning of treatment - Categorical diagnosis of PTSD (SCID 5 ) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment 2) Evaluation of efficacy on comorbid disorders - CDI score at the inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - DES-A score at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - Scores for Behavioral and Somatic Disorders and for School/social functioning (CBCL/YSR, parents/children) (Achenbach, 2001) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - Mini-Kid DSM4 part C score for suicidal risk at inclusion, 1 week after the end of treatment, 6 months and 12 months after the beginning of treatment - Spatial working memory test (Corsi Block) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment 3) Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks): Clinical evaluation (cardiac rate, blood pressure, general tolerance) ;Timepoint(s) of evaluation of this end point: 1) 12 months 2) 12 months 3) 7 weeks	—

Measure

Time frame

Secondary end point(s): 1) Symptomatic evolution of PTSD - PCL5 at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment, and 3, 6, 12 months after the beginning of treatment. - Functional impairment score (CPC- DSM5, Scheerringa) at the inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6, 12 months after the beginning of treatment - Categorical diagnosis of PTSD (SCID 5 ) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment 2) Evaluation of efficacy on comorbid disorders - CDI score at the inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - DES-A score at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - Scores for Behavioral and Somatic Disorders and for School/social functioning (CBCL/YSR, parents/children) (Achenbach, 2001) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment; - Mini-Kid DSM4 part C score for suicidal risk at inclusion, 1 week after the end of treatment, 6 months and 12 months after the beginning of treatment - Spatial working memory test (Corsi Block) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment 3) Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks): Clinical evaluation (cardiac rate, blood pressure, general tolerance) ;Timepoint(s) of evaluation of this end point: 1) 12 months 2) 12 months 3) 7 weeks

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Countries

France

Contacts

Public ContactDRI

Rennes University Hospital

marie-laure.gervais@chu-rennes.fr+33299283999

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026