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.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Catello Vollono, MD
- Número de teléfono: +390630154279
- Correo electrónico: catello.vollono@policlinicogemelli.it
Ubicaciones de estudio
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Lazio
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Rome, Lazio, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia
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Contacto:
- Catello Vollono, MD
- Número de teléfono: +390630154279
- Correo electrónico: catello.vollono@policlinicogemelli.it
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Investigador principal:
- Catello Vollono, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Response to Vortioxetine
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of depressive and anxiety symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Catello Vollono, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 7192
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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