Migraine Trial, Recruiting NCT07579481 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Migraine
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Migraine Trial, Recruiting

NCT07579481
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are over 18 years old
  • You have been diagnosed with depression (based on DSM-5 guidelines) and have recently started taking Vortioxetine (for no more than one week)
  • You have depression and may also have symptoms of anxiety
  • Your depression is rated as moderate to severe based on a standard scoring scale (HAM-D score above 18)
  • You have been diagnosed with episodic migraine (with or without aura) for at least one year before the study screening visit, and your migraines started before you were 50 years old
  • You are not currently taking any other treatments for depression alongside Vortioxetine
  • You are not currently on certain migraine prevention medications, such as older antidepressants (TCAs), other antidepressants, anti-CGRP injections, or gepants, and you are not considered a suitable candidate for anti-CGRP injections
  • Your current migraine treatment has been stable for at least two months and is not expected to change in the next 12 weeks
  • You are willing and able to provide written consent to participate

Who may not be able to join:

  • You have another significant pain condition, such as chronic back pain or fibromyalgia, that could affect the results
  • You have been diagnosed with certain other types of headache disorders, such as chronic tension-type headache, cluster headache, hypnic headache, hemicrania continua, new daily persistent headache, hemiplegic migraine, or migraine with brainstem aura
  • You have a personal history of psychosis or bipolar disorder (manic episodes)
  • You have signs of cognitive (memory or thinking) difficulties, based on a standard screening test (confirm with trial site)

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Catello Vollono, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phone: +390630154279

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 April 2025
Est. completion
30 May 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Response to Vortioxetine

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov