Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity
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
Complete details of migraine history and frequency of monthly migraine days in the past month
clinical indication to start fremanezumab therapy to prevent migraine in patients naïve to monoclonal antibodies targeting the CGRP pathway
In case of migraine preventive therapy and concomitant antidepressants, stability for at least 8 weeks prior to enrollment.
Presence of a caregiver (see definition below) of the patient
80% compliance with diary and ability to complete the scale to provide written informed consent.
INFORMAL CAREGIVERS:
Adult subjects, male or female.
Informal caregiver is defined as a person--spouse/partner, parent, child/child, sibling--who cares for the migraine patient, sharing the same household and performing various functions, from basic daily needs to socio-economic activities)
RSS score ≥ 1
80% compliance with completion scale ability to provide written informed consent
You may not be if
Patients:
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
Patient participating in another study at the same time as enrollment in the current study
Informal Caregivers:
History of migraine.
History of major depressive disorder and 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 caregiver 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.
Clareo Health | Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity
