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临床试验/NCT04305132
NCT04305132Unknown不适用

Can Electroconvulsive Therapy Alter Retinal Nerve Fiber Layer Thickness of Patients With Depression

Mehmet Diyaddin Güleken1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Changes of retinal nerve fiber layer thickness

研究概览

简要总结

The aim of this study is to investigate the changes in the retinal nerve fiber layer thickness of the patients with depression who received electroconvulsive therapy by means of optical coherence tomography.

详细描述

Major depression (MD) is a mood disorder that is common in the society, has negative effects on emotion, thought and behavior, and leads to significant impairments in functionality. Electroconvulsive therapy (ECT) is a highly effective and reliable biological treatment method used in psychiatric diseases for a long time. The most common use in psychiatry is depression. Studies have shown that ECT causes a broadly distributed increase in brain gray matter volume (especially the temporal lobe) in MD patients. Optical coherence tomography (OCT) is a non-invasive medical imaging method that displays biological tissue layers by taking high resolution tomographic sections. Alterations in the thickness of the retinal nerve fiber layer (RNFL), which is a layer of the ganglion cell complex in the retina of the eye and consists of ganglion cell axons, occur due to axonal damage in the retinal nerve tissue. Since RNFL is in a similar form with the brain gray matter tissue, recently, neurological and psychiatric studies have been conducted to provide data regarding the neurodegeneration occurring in the brain tissue. In the study, it is aimed to assess the possible cortical volume changes of patients by measuring changes in the retinal layers due to ECT in patients with depression. In other words, considering that ECT causes an increase in brain volume, it is to observe whether this increase is reflected in the retinal nerve fiber layer thickness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject diagnosed as unipolar depression
  • Subject with depression to be treated with electroconvulsive therapy
  • Subject with depression having a Standardized Mini Mental Test score of >23

排除标准

  • Any comorbid psychiatric condition (including alcohol / substance use)
  • Having any major neurological (i.e.: cerebrovascular disease, multiple sclerosis, etc.) disease
  • Having any major medical (i.e.: diabetes mellitus, myocardial infarction, etc.) disease
  • History of or having any ocular trauma, disease or surgery, any retinal disease, refraction defect
  • To be treated with electroconvulsive therapy in the last 6 months

结局指标

主要结局

Changes of retinal nerve fiber layer thickness

时间窗: About 4 weeks

Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy

次要结局

未报告次要终点

研究者

发起方
Mehmet Diyaddin Güleken
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Diyaddin Güleken

MDGuleken

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

研究点 (1)

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