Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

Phase 1

• Conditions: Post-Traumatic Stress Disorder and fibromyalgia syndrome; MedDRA version: 21.1Level: LLTClassification code 10057246Term: Prolonged post-traumatic stress disorderSystem Organ Class: 100000004873; MedDRA version: 20.0Level: LLTClassification code 10016631Term: Fibromyalgia syndromeSystem Organ Class: 100000004859; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2021-000312-36-FR
• Lead Sponsor: Henri Laborit Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-24
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Adult over 18 years old
- Diagnosis of fibromyalgia syndrome according to ACR 2016 criteria
-PCL-5 > 44 suggesting the presence of a comorbid post-traumatic stress disorder
-Meet the DSM-5 criteria for post-traumatic stress disorder secondary to exposure to a traumatic event according to DSM-5 criteria, both unique or repeated and regardless of the date or location of the traumatic event.
-Pain relief treatment and/or psychotropic treatment stabilized for a period greater than or equal to two months.
-Signature of a consent form
-Patient able to understand and read french

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Psychotic disorders
-Unstable bipolar disorder
-Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as established during the initial visit
-Significant anormal ECG
-Medical contraindication to taking propranolol
-Adverse reactions or previous intolerances to a beta blocker
-Current intake of another beta blocker which can not be stopped during the protocol, regardeless the galenic.
-Current intake of a drug with potential contraindication with the propranolol, according to the summary of product characteristics of the propranolol.
-Patient under legal protection, under guardianship or under curatorship
-Patient having suffered a head trauma for less than a year or with clinical symptoms and neurological sequelae
-Known severe suicide risk (MINI-S and medical exam)
-Current opioid addiction or alcohol dependence
-Patients treated for less than 2 months with antidepressants or painkillers
-Patients unafiliated to a social health care
-Woman who is pregnant or breast-feeding or whithout efficient contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified