Actively Recruiting
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
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-06-19
300
Participants Needed
10
Research Sites
77 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Campus Bio-Medico
Lead Sponsor
T
Teva Pharmaceuticals USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, male or female
- Diagnosis of migraine, with or without aura, or chronic migraine, according to the International Classification of Headaches (ICHD-3)
- Migraine onset before age 50
- Depressive symptoms with PHQ-9 score of 5 or higher
- Complete migraine history and monthly migraine day frequency recorded
- Clinical indication to start fremanezumab therapy; patients naive to monoclonal antibodies targeting CGRP pathway
- Stable migraine preventive therapy and antidepressants for at least 8 weeks if used
- Presence of an informal caregiver living in the same household
- At least 80% compliance with diary and ability to complete scales
- Informal caregiver adult, male or female
- Informal caregiver defined as spouse/partner, parent, child, or sibling who shares household and provides care
- Caregiver RSS score of 1 or higher
- Caregiver able to provide informed consent and complete scales with 80% compliance
You will not qualify if you...
- Patients without a caregiver
- Contraindications or no indication for fremanezumab
- Patients with clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease or infection complications
- Patients with severe or uncontrolled psychiatric disorders (bipolar disorders, schizophrenia, psychosis) that interfere with study participation
- Patients participating in another study concurrently
- Informal caregivers with a history of migraine
- Informal caregivers with major depressive disorder or severe/uncontrolled psychiatric disorders
- Caregivers with clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, ocular disease or infection complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, Italy, 00145
Actively Recruiting
2
Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI
Ancona, Italy
Actively Recruiting
3
PO Avezzano "S.Filippo e Nicola"
Avezzano, Italy
Actively Recruiting
4
Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy
Actively Recruiting
5
IRCCS Istituto Scienze Neurologiche
Bologna, Italy
Actively Recruiting
6
ASST Spedali Civili Brescia
Brescia, Italy
Actively Recruiting
7
Fondazione IRCCS Istituto Neurologico "Carlo Besta
Milan, Italy
Actively Recruiting
8
Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli
Naples, Italy
Actively Recruiting
9
IRCCS San Raffaele Pisana
Rome, Italy
Actively Recruiting
10
Ospedale Fabenefratelli- San Pietro
Rome, Italy
Actively Recruiting
Research Team
C
Claudia Altamura, MD, PhD
CONTACT
L
Luisa Fofi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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