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

Official title

Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Prospective Real-life Observational Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity

Overview

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.

Interventions

• Drug Fremanezumab
  subcutaneous injection 225 mg monthly or 675 mg quarterly

Primary outcome measures

• CHANGE in caregiver stress [Time frame: from baseline to evaluation at 6 months after fremanezumab therapy]

Secondary outcome measures (5)

• CHANGE IN RECIPROCITY [Time frame: from baseline to the evaluation after 6 months of therapy with fremanezumab]
• CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress [Time frame: from baseline to 6 months after fremanezumab therapy]
• CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES [Time frame: from baseline to 6 months after therapy with fremanezumab]
• PATIENT ANXIETY AND CAREGIVER STRESS [Time frame: from baseline to 6 months after fremanezumab therapy]
• PATIENT DISABILTY AMD CAREGIVER STRESS [Time frame: from baseline to 6 months after fremanezumab therapy]

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/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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Italy · 10 centers

• Fondazione Policlinico Universitario Campus Bio-Medico — Rome
• Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI — Ancona
• PO Avezzano "S.Filippo e Nicola" — Avezzano
• Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinic — Bari
• IRCCS Istituto Scienze Neurologiche — Bologna
• ASST Spedali Civili Brescia — Brescia
• Fondazione IRCCS Istituto Neurologico "Carlo Besta — Milan
• Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luig — Naples
• … and 2 more centers

Identifiers

NCT: NCT07029126 · MI_DEAR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗