Migraine
Conditions
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.
Interventions
DRUGFremanezumab
subcutaneous injection 225 mg monthly or 675 mg quarterly
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Teva Pharmaceuticals USA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHANGE in caregiver stress | from baseline to evaluation at 6 months of fremanezumab therapy | Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CHANGE IN RECIPROCITY | from baseline to the evaluation at 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 (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) and 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 in reciprocity (MUTUALITY SCALE, range 0-4 higher score inficate higher mutuality) 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 |
Countries
Italy
Outcome results
None listed