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NCT Number: NCT07579481

Vortioxetine in Depression and Concomitant Migraine

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Catello Vollono, MD

CONTACT

[email protected]

+390630154279

Catello Vollono, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Response to Vortioxetine

    Time frame: 6 months

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

Secondary outcomes

  1. Change of depressive and anxiety symptoms

    Time frame: 6 months

    To evaluate the response to VO in term of change of depressive and anxiety symptoms through clinical examination and questionnaire administration

  2. Change of migraine outcomes

    Time frame: 6 months

    To evaluate the response to VO in term of change of migraine outcomes through clinical examination and questionnaire administration

  3. Change of a specific biomarkers

    Time frame: 6 months

    To evaluate the response to VO in term of change of a specific biomarkers by measuring endocannabinoid levels before and after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Catello Vollono, MD

CONTACT

[email protected]

+390630154279

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Vortioxetine in the Treatment of Depression and Concomitant Migraine: an Explorative Study

Acronym: VORTIX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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