EUCTR2021-000312-36-FR
Active, Not Recruiting
Phase 1
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome - PTSD-FMS
Henri Laborit Hospital0 sites25 target enrollmentMarch 24, 2021
ConditionsPost-Traumatic Stress Disorder and fibromyalgia syndromeMedDRA version: 21.1Level: LLTClassification code 10057246Term: Prolonged post-traumatic stress disorderSystem Organ Class: 100000004873MedDRA version: 20.0Level: LLTClassification code 10016631Term: Fibromyalgia syndromeSystem Organ Class: 100000004859Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
DrugsAvlocardyl
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post-Traumatic Stress Disorder and fibromyalgia syndrome
- Sponsor
- Henri Laborit Hospital
- Enrollment
- 25
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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