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Could this pill tame both depression and migraine? new study investigates

NCT ID NCT07579481

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the antidepressant vortioxetine can help people who suffer from both depression and migraine. Researchers will track 31 adults over 12 weeks to see if their mood and headache symptoms improve. The goal is to find a treatment that works for both conditions at once.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 31 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia

    RECRUITING

    Rome, Lazio, 00168, Italy

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