Vortioxetine in Depression and Concomitant Migraine

Recruiting now

Conditions studied: Depression, Migraine

In brief

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.

Key facts

Study ID: NCT07579481
Run by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
People needed: 31
Starts: 2025-04-28
Expected to finish: 2026-09-30
Last updated by the study team: 2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia — Rome, Lazio, Italy (enrolling)

Full record on ClinicalTrials.gov

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