Vortioxetine in Depression and Concomitant Migraine

NCT07579481 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Observational

Started

2025-04-28

Last updated

2026-05-12

Condition(s) studied

DepressionMigraine

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Response to Vortioxetine — 6 months
To evaluate the modification of depression after 12 weeks of treatment with Vortioxetine (VO) through clinical examination and questionnaire administration

Trial sites (1)

Facility	City	Region	Status
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia	Rome	Lazio	Recruiting

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

The Management of Asymptomatic Carotid Stenosis Recruiting

Modular Neurological Examination for Early Risk Detection Active, not recruiting

Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab. Recruiting

BRCA Mutation Carriers' Platform a Multicenter Study Recruiting

Superior Cervical Ganglion in Parkinson's Disease Recruiting

Other trials for the same condition

Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables Recruiting

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects Recruiting

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment Recruiting

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine Active, not recruiting

The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07579481 on ClinicalTrials.gov ↗ ← All trials in Italy