Study of Fremanezumab Treatment to Reduce Stress and Improve Relationship Quality in Caregivers of Adults With Migraine and Depressive Symptoms

What this Trial Is About

This research aims to evaluate the reduction of emotional burden experienced by caregivers of migraine patients who also have depressive symptoms. The study focuses on assessing caregivers stress levels using the Relative Stress Scale RSS over six months following the initial injection of fremanezumab. It also explores the impact on mutual support between patients and caregivers, known as couple reciprocity. Participants include adult migraine patients diagnosed according to the International Classification of Headaches ICHD-3 and their informal caregivers who live in the same household. Patients will receive fremanezumab via subcutaneous injections, either 225 mg monthly or 675 mg quarterly, as part of their migraine prevention therapy. The study observes these treatments in a real-life setting without experimental manipulation. Throughout the six-month study, caregivers and patients will complete assessments measuring stress, reciprocity, depression, anxiety, and disability. Researchers will track changes from baseline to six months after starting fremanezumab therapy. The study involves diary compliance, written consent, and continuous monitoring of both patients and caregivers to understand how treatment affects their emotional well-being and relationship dynamics.

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