Phase
Condition
Fibromyalgia
Post-traumatic Stress Disorders
Treatment
Propranolol
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 toa traumatic event according to DSM-5 criteria, both unique or repeated andregardless of the date or location of the traumatic event.
Pain relief treatment and/or psychotropic treatment stabilized for a period greaterthan or equal to two months.
Signature of a consent form
Patient able to understand and read french
Exclusion
Exclusion Criteria:
Psychotic disorders
Unstable bipolar disorder
Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as establishedduring 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 symptomsand 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
Connect with a study center
Centre Hospitalier Henri Laborit
Poitiers,
FranceActive - Recruiting
Centre Hospitalier Nord-Deux-Sèvres
Thouars,
FranceActive - Recruiting
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