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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04305132
• Other study ID #: MDGuleken
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2021
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: Mehmet D Güleken, MD
• Phone: +905063282603
• Email: mdguleken[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Electroconvulsive therapy
Thymatron System IV electroconvulsive therapy device

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Gazi Yasargil Tranining and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Diyaddin Güleken

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Gazdag G, Ungvari GS. Electroconvulsive therapy: 80 years old and still going strong. World J Psychiatry. 2019 Jan 4;9(1):1-6. doi: 10.5498/wjp.v9.i1.1. eCollection 2019 Jan 4. — View Citation

Mutlu U, Colijn JM, Ikram MA, Bonnemaijer PWM, Licher S, Wolters FJ, Tiemeier H, Koudstaal PJ, Klaver CCW, Ikram MK. Association of Retinal Neurodegeneration on Optical Coherence Tomography With Dementia: A Population-Based Study. JAMA Neurol. 2018 Oct 1;75(10):1256-1263. doi: 10.1001/jamaneurol.2018.1563. — View Citation

Ousdal OT, Argyelan M, Narr KL, Abbott C, Wade B, Vandenbulcke M, Urretavizcaya M, Tendolkar I, Takamiya A, Stek ML, Soriano-Mas C, Redlich R, Paulson OB, Oudega ML, Opel N, Nordanskog P, Kishimoto T, Kampe R, Jorgensen A, Hanson LG, Hamilton JP, Espinoza R, Emsell L, van Eijndhoven P, Dols A, Dannlowski U, Cardoner N, Bouckaert F, Anand A, Bartsch H, Kessler U, Oedegaard KJ, Dale AM, Oltedal L; GEMRIC. Brain Changes Induced by Electroconvulsive Therapy Are Broadly Distributed. Biol Psychiatry. 2020 Mar 1;87(5):451-461. doi: 10.1016/j.biopsych.2019.07.010. Epub 2019 Jul 25. — View Citation

Pan J, Zhou Y, Xiang Y, Yu J. Retinal nerve fiber layer thickness changes in Schizophrenia: A meta-analysis of case-control studies. Psychiatry Res. 2018 Dec;270:786-791. doi: 10.1016/j.psychres.2018.10.075. Epub 2018 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of retinal nerve fiber layer thickness	Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy	About 4 weeks