Assesment of Retinal Nerve Fiber Layer in First Episode Depressive Patients Using Selective Serotonin Reuptake Inhibitor

Sponsor

Mehmet Diyaddin Güleken (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04717921

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the changes in retinal nerve fiber layer due to SSRI treatment in first-attack major depressive patients.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression

Detailed Description

Selective serotonin reuptake inhibitors (SSRIs) are among the most used and safe antidepressant drugs in the world. In previous studies, SSRIs have been found to cause an increase in brain gray matter volume in patients with major depression (MD). Optical coherence tomography (OCT) is a non-invasive medical imaging method that displays biological tissue layers by taking high-resolution tomographic sections. Changes in the thickness of the retinal nerve fiber layer (RNFL), a layer of the ganglion cell complex in the retinal layer of the eye and composed of ganglion cell axons, occur due to axonal damage in the retinal nerve tissue. Since RNFL is similar to brain gray matter tissue, recently neurological and psychiatric studies have been conducted to provide data on the neurodegeneration that occurs in the brain by OCT. However, in a recent cross-sectional study, contrary to what was expected, thinning of the retinal nerve fiber layer was detected in psychiatric patients using SSRI drugs compared to the healthy group, and this was attributed to a probable maculopathy caused by SSRIs in the eye. In this study, it is aimed to assess the probable cortical volume changes of the patients by measuring the changes in retinal nerve layers due to SSRI treatment in first-attack MD patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Can Selective Serotonin Reuptake Inhibitor Drugs Alter Retinal Nerve Fiber Layer Thickness in First Episode Depressive Patients?

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients Subjects with unipolar depression
Healthy Healthy Control Group

Outcome Measures

Primary Outcome Measures

Change in Retinal nerve fiber layer thickness [Baseline, at first week and at the 8th week of the treatment]
Retinal nerve fiber layer thickness change during selective serotonin reuptake inhibitor treatment in first attack depressive subjects

Secondary Outcome Measures

Choroid thickness [Baseline, at first week and at the 8th week of the treatment]
Choroid thickness change during selective serotonin reuptake inhibitor treatment in first attack depressive subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

First attack depressive patients between 18 and 65 years
Diagnosed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 / Clinical Version (SCID-5 / CV)
Started to be treated with selective serotonin reuptake inhibitors
Having a Standardized Mini Mental Test (SMMT) score of 24 or more and
Healthy subjects with no psychiatric history, having a SCL-90-R (GSI) score of less than 1.0

Exclusion Criteria:

Depressive subjects with any neurological (cerebrovascular disease, head trauma, intracranial mass, dementia, epilepsy, multiple sclerosis, etc.) or general medical (such as diabetes, hypertension, myocardial infarction, etc.) diagnosis, with an ocular surgery or a history of ocular trauma, retinal pathology (detachment, etc.), other eye pathologies such as optic nerve neuropathy and refractive error, previous history of antidepressant drug use, alcohol-substance abuse or addiction,
Healthy individuals with a history of psychiatric diagnosis or a SCL-90-R (GSI) score of 1.0 or above