Vortioxetine in Depression and Concomitant Migraine

NCT07579481 | Recruiting

• 1 other identifier: 7192
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Migraine

Outcome Measures

Primary Outcomes (1)

• Response to Vortioxetine

  To evaluate the modification of depression after 12 weeks of treatment with Vortioxetine (VO) through clinical examination and questionnaire administration

  6 months

Secondary Outcomes (3)

• Change of depressive and anxiety symptoms

  6 months

• Change of migraine outcomes

  6 months

• Change of a specific biomarkers

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of depression, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and concomitant episodic migraine with or without aura, fulfilling the criteria of ICHD-3.

You may qualify if:

• The patient is aged \>18 years old
• The patient has a diagnosis of depression, according to DSM-5, and in treatment with Vortioxetine (for no more than a week).
• Patients with depression and anxiety symptoms will also be included in the study
• The patient had a score of the HAM-D \>18 (moderate to severe)
• The patient has a diagnosis of episodic migraine with and without aura according to ICHD-3 criteria confirmed at the Screening Visit with a history of migraine onset of at least one year before the Screening Visit
• No concomitant other treatment for depression
• The patient has had an onset of migraine at \<50 years of age
• All participating patients will provide written informed consent
• No concomitant preventive treatment for migraine with TCAs, other antidepressants, anti-CGRP monoclonal antibodies (mAbs) or gepants. The patient is not eligible for treatment with anti-CGRP mAbs
• Stable treatment for migraine for at least two months without prevision to change it in the next two12 weeks

You may not qualify if:

• The patient has confounding and clinically significant pain syndromes (for example, chronic low back pain and fibromyalgia)
• The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), or migraine with brainstem aura
• Patients with a lifetime history of psychosis, bipolar mania
• Patients with cognitive impairment are excluded (MoCA \<26)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Depression; Migraine Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Catello Vollono, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catello Vollono, MD

CONTACT

+390630154279; catello.vollono@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: May 12, 2026
• Study Start: April 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IT (1)