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

NCT ID: NCT04305132

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Depression

Subjects with depression treated with electroconvulsive therapy

Electroconvulsive therapy

Intervention Type DEVICE

Thymatron System IV electroconvulsive therapy device

Healthy

Healthy subjects

No interventions assigned to this group

Interventions

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Electroconvulsive therapy

Thymatron System IV electroconvulsive therapy device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mehmet Diyaddin Güleken

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Diyaddin Güleken

MDGuleken

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mehmet D Güleken, MD

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Locations

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Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet D Güleken, MD

Role: CONTACT

+905063282603

Hasan Öncül, MD

Role: CONTACT

+905357624011

Facility Contacts

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Mehmet D Güleken, MD

Role: primary

+905063282603

References

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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.

Reference Type BACKGROUND
PMID: 30631748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31561859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30551326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29946702 (View on PubMed)

Other Identifiers

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MDGuleken

Identifier Type: -

Identifier Source: org_study_id

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