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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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

31

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Lazio
      • Rome、Lazio、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Neurofisiopatologia
        • 接触:
        • 首席研究员:
          • Catello Vollono, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Response to Vortioxetine
大体时间:6 months
To evaluate the modification of depression after 12 weeks of treatment with Vortioxetine (VO) through clinical examination and questionnaire administration
6 months

次要结果测量

结果测量
措施说明
大体时间
Change of depressive and anxiety symptoms
大体时间:6 months
To evaluate the response to VO in term of change of depressive and anxiety symptoms through clinical examination and questionnaire administration
6 months
Change of migraine outcomes
大体时间:6 months
To evaluate the response to VO in term of change of migraine outcomes through clinical examination and questionnaire administration
6 months
Change of a specific biomarkers
大体时间:6 months
To evaluate the response to VO in term of change of a specific biomarkers by measuring endocannabinoid levels before and after treatment
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Catello Vollono, MD、Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月28日

初级完成 (估计的)

2026年5月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2024年11月21日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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