Effect of Electroconvulsive Therapy on Retinal Nerve Fiber Layer Thickness in Depression

• Conditions: Depression
• Interventions: Device: Electroconvulsive therapy

• Registration Number: NCT04305132
• Lead Sponsor: Mehmet Diyaddin Güleken

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-27
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depression	Electroconvulsive therapy	Subjects with depression treated with electroconvulsive therapy

Primary Outcome Measures

Name	Time	Method
Changes of retinal nerve fiber layer thickness	About 4 weeks	Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy

Trial Locations

Locations (1)

Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital; 🇹🇷 Diyarbakır, Turkey