Vortioxetine for adults with depression who also have migraine
Vortioxetine in the Treatment of Depression and Concomitant Migraine: an Explorative Study
This project will try to see if taking vortioxetine helps adults with major depression who also have episodic migraine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT07579481 on ClinicalTrials.gov |
What this trial studies
This is an observational study that follows adults with DSM-5 major depression who have recently started vortioxetine and also have episodic migraine. Participants must have a HAM-D score >18, a history of episodic migraine confirmed by ICHD-3 criteria, be on vortioxetine for one week or less, and not be taking other antidepressants or certain migraine preventives. Investigators will track depressive symptoms, migraine frequency and severity, and quality-of-life measures over time. All visits occur at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and require informed consent.
Who should consider this trial
Good fit: Adults (over 18) with DSM-5 major depression (HAM-D >18) who have episodic migraine per ICHD-3, have started vortioxetine within the past week, and are not on other antidepressants or certain migraine preventive treatments.
Not a fit: Patients already taking other antidepressants or on anti-CGRP monoclonal antibodies, gepants, or other excluded migraine preventives, those with chronic migraine or migraine onset after age 50, or those not willing/able to attend the Rome site are unlikely to be eligible or derive insight from this study.
Why it matters
Potential benefit: If successful, vortioxetine could reduce depressive symptoms and might also lower migraine frequency or severity, improving overall quality of life.
How similar studies have performed: Some antidepressant classes (for example, tricyclics and certain SNRIs) have shown benefit for comorbid migraine and depression, but vortioxetine's specific effects on migraine are relatively untested and data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Catello Vollono, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Catello Vollono, MD
- Email: catello.vollono@policlinicogemelli.it
- Phone: +390630154279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.