To evaluate the reduction of emotional burden (measured by Relative Stress Scale-RSS) of caregivers of migraine patients with Depressive Symptoms after 6 months after the first injection of fremanezumab.
Adult patients, male or female
Diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3.)
Diagnosis of migraine with onset at an age of less than 50 years
Depressive symptoms in patients defined as a Patient Health Questionnaire PHQ-9 scale score ≥5
Patients without a caregiver
Contraindications or lack of indication to fremanezumab
The patient has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, ocular disease, or complications of an infection, at the discretion of the investigator
Patient with a clinical history of a severe or uncontrolled psychiatric disorder (bipolar disorders, schizophrenia, psychosis), at the discretion of the investigator, that would likely interfere with full participation in the study
The study population will be composed of female and male patients aged \>18 with a diagnosis of migraine with and without aura (as defined by the International Classification of Headache Disorders, ICHD-3)15. Patients must have been diagnosed with migraine at least 12 months before the baseline visit, and the diagnosis of migraine will be confirmed via a review of the medical chart and of a 4-week headache diary before the baseline visit. Only patients with an indication to start a new preventive medication with fremanezumab and their caregivers will be enrolled.
Cohort
Prospective
Fremanezumab
Drugsubcutaneous injection 225 mg monthly or 675 mg quarterly
CHANGE in caregiver stress
Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress)
CHANGE IN RECIPROCITY
To evaluate an increase in reciprocity within the mutuality scale in the caregiver/ migraine patient dyad after 6 months from the first injection of fremanezumab. Reciprocity represents the mean value of the response to questions 5, 6, 10, 13, and 15 of the mutuality scale (raging from 0, lower reciprocity, to 4 higher reciprocity)
CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress
to evaluate whether the change in depression (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers.
CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES
To evaluate whether the CHANGE in depressive (PHQ-9 SCALE) and anxiety (STAY SCALE) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change in reciprocity (MUTUALITY SCALE) between patient and caregiver
PATIENT ANXIETY AND CAREGIVER STRESS
to evaluate whether the change in anxiety (STATE-TRAIT ANXIETY INVENTORY STAY, range 20-80, from 40 points to higher scores indicate anxiety) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers
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Fondazione Policlinico Universitario Campus Bio-Medico
Lead sponsor
Teva Pharmaceuticals USA
Collaborator
