Vortioxetine in Depression and Concomitant Migraine (VORTIX)
Vortioxetine in the Treatment of Depression and Concomitant Migraine: an Explorative Study
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.
Studieoversikt
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Catello Vollono, MD
- Telefonnummer: +390630154279
- E-post: catello.vollono@policlinicogemelli.it
Studiesteder
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Lazio
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Rome, Lazio, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia
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Ta kontakt med:
- Catello Vollono, MD
- Telefonnummer: +390630154279
- E-post: catello.vollono@policlinicogemelli.it
-
Hovedetterforsker:
- Catello Vollono, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Response to Vortioxetine
Tidsramme: 6 months
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To evaluate the modification of depression after 12 weeks of treatment with Vortioxetine (VO) through clinical examination and questionnaire administration
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change of depressive and anxiety symptoms
Tidsramme: 6 months
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To evaluate the response to VO in term of change of depressive and anxiety symptoms through clinical examination and questionnaire administration
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6 months
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Change of migraine outcomes
Tidsramme: 6 months
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To evaluate the response to VO in term of change of migraine outcomes through clinical examination and questionnaire administration
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6 months
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Change of a specific biomarkers
Tidsramme: 6 months
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To evaluate the response to VO in term of change of a specific biomarkers by measuring endocannabinoid levels before and after treatment
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6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Catello Vollono, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7192
Legemiddel- og utstyrsinformasjon, studiedokumenter
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