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

• Conditions: Migraine
• Interventions: Drug: Fremanezumab

• Registration Number: NCT07029126
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-03
• Status Verified: 2024-12
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2025-10-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PATIENTS	Fremanezumab	Adult male or female patients with diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3.)

Primary Outcome Measures

Name	Time	Method
CHANGE in caregiver stress	from baseline to evaluation at 6 months after fremanezumab therapy	Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress)

Secondary Outcome Measures

Name	Time	Method
CHANGE IN RECIPROCITY	from baseline to the evaluation after 6 months of therapy with fremanezumab	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	from baseline to 6 months after fremanezumab therapy	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	from baseline to 6 months after therapy with fremanezumab	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	from baseline to 6 months after fremanezumab therapy	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
PATIENT DISABILTY AMD CAREGIVER STRESS	from baseline to 6 months after fremanezumab therapy	to evaluate whether the change in anxiety disability (MiGRAINE DISABILITY ASSESSMENT MIDAS raging from 0 to 270, higher scores indicate greater disability) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers

Trial Locations

Locations (10)

Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI; 🇮🇹 Ancona, Italy

PO Avezzano "S.Filippo e Nicola"; 🇮🇹 Avezzano, Italy

Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy

IRCCS Istituto Scienze Neurologiche; 🇮🇹 Bologna, Italy

ASST Spedali Civili Brescia; 🇮🇹 Brescia, Italy

Fondazione IRCCS Istituto Neurologico "Carlo Besta; 🇮🇹 Milan, Italy

Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli; 🇮🇹 Naples, Italy

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, Italy

IRCCS San Raffaele Pisana; 🇮🇹 Rome, Italy

Ospedale Fabenefratelli- San Pietro; 🇮🇹 Rome, Italy