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Clinical Trials/EUCTR2020-001878-29-FR
EUCTR2020-001878-29-FR
Active, not recruiting
Phase 1

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

Rennes University Hospital0 sites74 target enrollmentNovember 23, 2020
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Conditionspost-traumatic stress disorderMedDRA version: 21.1Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
post-traumatic stress disorder
Sponsor
Rennes University Hospital
Enrollment
74
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 23, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rennes University Hospital

Eligibility 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.

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;

Outcomes

Primary Outcomes

Not specified

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