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

NCT04305132 | Unknown FDA Device

• 1 other identifier: MDGuleken
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; electroconvulsive therapy; retinal nerve fiber layer; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Depression

Subjects with depression treated with electroconvulsive therapy

Device: Electroconvulsive therapy

Healthy

Healthy subjects

Interventions

Electroconvulsive therapy DEVICE

Thymatron System IV electroconvulsive therapy device

Depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehmet Diyaddin Güleken: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 30631748 BACKGROUND

• 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.

  PMID: 31561859 BACKGROUND

• 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.

  PMID: 30551326 BACKGROUND

• 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.

  PMID: 29946702 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mehmet D Güleken, MD

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Mehmet D Güleken, MD

CONTACT

+905063282603; mdguleken@hotmail.com

Hasan Öncül, MD

CONTACT

+905357624011; hasan.oncul@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MDGuleken

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: January 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available with six months of study completion.
• Access Criteria: Data access requests will be reviewed by an independent reviewer. Requestors will be required to sign a Data Access Agreement.

Locations

TU (1)