An observational study in Depression, sponsored by Mehmet Diyaddin Güleken. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Mehmet Diyaddin Güleken · Observational
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 50 is below the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →Mehmet Diyaddin Güleken is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
Subjects with depression treated with electroconvulsive therapy
Device: Electroconvulsive therapy
Healthy subjects
Thymatron System IV electroconvulsive therapy device
Changes of retinal nerve fiber layer thickness
Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy
Time frame: About 4 weeks
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Sap, Icf
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Mehmet Diyaddin Güleken