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.
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
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
Fondazione Policlinico Universitario Campus Bio-Medico
Lead sponsor
Teva Pharmaceuticals USA
Collaborator