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Vortioxetine in Depression and Concomitant Migraine

NCT07579481 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2026-05-12

No results posted yet for this study

Summary

Depression and migraine are among the most prevalent conditions in the general population, and many research shows they are closely related. Migraine is one of the most common debilitating diseases, affecting over one billion people worldwide. Migraine is frequently comorbid with psychiatric conditions such as anxiety disorders and major depression, with a negative impact on quality of life (QoL) and disability.

The knowledge of the pathophysiology of migraine involves changes in physiological processes, functional connectivity, and structural changes of the central nervous system (CNS) in patients with underlying genetic susceptibility. Upregulation of vasoactive and pro-inflammatory mediators such as calcitonin gene-related peptide (CGRP) and cytokines have been found in the trigeminal ganglia and the plasma, cerebrospinal fluid, saliva, and tears of these patients.

Various classes of antidepressants - like Selective Serotonin Reuptake Inhibitors (SSRI), Selective Serotonin and Norepinephrine Inhibitors (SNRI), and Tricyclic Antidepressants (TCAs) - were investigated but in a low number of studies and with inconsistent results.

Vortioxetine (VO) is a novel multimodal serotonergic antidepressant, approved in the last decade for the treatment of major depression. VO inhibits 5-HT transporter (SERT), like commonly used antidepressants, but different from them, it directly modulates the activity of 5-HT receptors. Vortioxetine also modifies the release of glutamate and gamma amino butyric acid (GABA), implicated in migraine pathogenesis. Recent experimental and clinical studies have shown that VO exerts antidepressant and pro-cognitive activities and is also effective in modulating pain hypersensitivity and could be effective in treating chronic pain syndromes.

Conditions

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Catello Vollono, MD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2026-05-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579481 on ClinicalTrials.gov