AzTrials
AzTrials

DepressionVORTIXNCT07579481

Vortioxetine in Depression and Concomitant Migraine

An observational study of Depression and Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Migraine
How many people
31 participants
Where
1 siteItaly
Study dates
28 Apr 2025to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catello Vollono, MD contact

+390630154279

catello.vollono@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia

    Rome, Lazio, 00168

    Catello Vollono, MD, +390630154279, catello.vollono@policlinicogemelli.it

    Catello Vollono, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read more

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
Medical subject headings
Depression, Migraine Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to Vortioxetine

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

    Measured: 6 months

Secondary outcomes (3)

  1. Change of depressive and anxiety symptoms

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

    Measured: 6 months

  2. Change of migraine outcomes

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

    Measured: 6 months

  3. Change of a specific biomarkers

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start28 Apr 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07579481
Sponsor's protocol ID
7192
Acronym
VORTIX
Status last verified
May 2026
First submitted
21 Nov 2024
Last updated
12 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Migraine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catello Vollono, MD (+390630154279, catello.vollono@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to Vortioxetine (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07579481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in