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.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Catello Vollono, MD
- Número de telefone: +390630154279
- E-mail: catello.vollono@policlinicogemelli.it
Locais de estudo
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Lazio
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Rome, Lazio, Itália, 00168
- Recrutamento
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia
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Contato:
- Catello Vollono, MD
- Número de telefone: +390630154279
- E-mail: catello.vollono@policlinicogemelli.it
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Investigador principal:
- Catello Vollono, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Response to Vortioxetine
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of depressive and anxiety symptoms
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 7192
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