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
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: PATIENTS * 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 * 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/par