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

Recruiting now

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT07029126

Run by

Fondazione Policlinico Universitario Campus Bio-Medico

People needed

300

Starts

2024-10-03

Expected to finish

2026-03-30

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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/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 qualify 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.

Where it is running

• Fondazione Policlinico Universitario Campus Bio-Medico — Rome, Italy, Italy (enrolling)
• Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI — Ancona, Italy (enrolling)
• PO Avezzano "S.Filippo e Nicola" — Avezzano, Italy (enrolling)
• Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari — Bari, Italy (enrolling)
• IRCCS Istituto Scienze Neurologiche — Bologna, Italy (enrolling)
• ASST Spedali Civili Brescia — Brescia, Italy (enrolling)
• Fondazione IRCCS Istituto Neurologico "Carlo Besta — Milan, Italy (enrolling)
• Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli — Naples, Italy (enrolling)
• IRCCS San Raffaele Pisana — Rome, Italy (enrolling)
• Ospedale Fabenefratelli- San Pietro — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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