Vortioxetine for adults with depression who also have migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.