Elevated CGRP levels in chronic migraine: investigating the risk of developing major depressive disorder. A prospective observational cohort study
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BACKGROUND: Chronic migraine (CM) is a common and disabling neurologic condition
that affects all areas of the patient's life. Major depressive disorder (MDD) is one of the
most frequent psychiatric disorders and is recognized to be the second most disabling
condi:on worldwide. Recent studies have shown a bidirec:onal relationship between
CM and MDD, where patients with CM are at higher risk of developing MDD, and vice
versa, leading to increased disability and reduced quality of life. It has been suggested
that both conditions may share different aspects in terms of genetics,
pathophysiological mechanisms, clinical features and treatment. Among common
pathways, evidence indicates that CGRP, a neuropeptide well known for its role in
migraine pathophysiology, has also emerged as a possible mediator of mood regulation.
This suggests that CGRP could explain the high comorbidity of migraine and depression,
however, further research is needed to fully comprehend its dual role.
OBJECTIVES: The aim of this study is to explore the relationship between CM and MDD
by evaluating the role of CGRP in identifying individuals at heightened risk of
comorbidity. Secondary objectives include assessing the likelihood of MDD relapse, the
severity of depressive symptoms and the impact on quality of life.
DESIGN: The study is designed as a prospective, observational, cohort study that will be
carried out in the Xarxa de Salut Mental i Addiccions (XSMiA) of the Girona province.
The follow-up period will be 2 years.
PARTICIPANTS AND METHODS: A total of 528 patients diagnosed with CM will we
recruited using a non-probabilistic convenience method, and those who fulfil the criteria
and sign the informed consent will be included. Data collection will include blood
samples to determine CGRP levels using the ELISA assay, alongside psychological
assessments using validated scales. The results will be analyzed through a descriptive,
bivariate and multivariate analysis by a professional statistician