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

January 24, 2021 updated by: Mehmet Diyaddin Güleken

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Diyarbakır, Turkey, 21070
        • Recruiting
        • Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include 25 volunteered inpatient or outpatient subjects with depression diagnosed with Structured Clinical Interview for DSM 5 Clinical Version (SCID 5/CV) who are followed-up at the Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital and 25 healthy volunteers matched with these patients in terms of age and gender. In order to measure the severity of the disease, subjects with depression will be administered Hamilton Depression Rating Scale (HAM-D), Young Mania Rating Scale (YMRS) and Clinical Global Impression Scale (CGI) before ECT, after the first ECT session and after the last ECT last session. The Symptom Check List-90-Revised (SCL-90-R) will be administered to healthy volunteers after enrollment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Depression
Subjects with depression treated with electroconvulsive therapy
Device: Electroconvulsive therapy
Thymatron System IV electroconvulsive therapy device
Healthy
Healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of retinal nerve fiber layer thickness
Time Frame: About 4 weeks
Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy
About 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Diyaddin Güleken

Investigators

  • Study Director: Mehmet D Güleken, MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDGuleken

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available with six months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an independent reviewer. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Electroconvulsive therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe