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

• ClinicalTrials.gov Identifier: NCT04717921
• Recruitment Status: Enrolling by invitation
• First Posted: January 22, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Mehmet Diyaddin Güleken
• Information provided by (Responsible Party): Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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
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
• Estimated 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: September 1, 2020
• Estimated Primary Completion Date: May 30, 2021
• Estimated Study Completion Date: September 1, 2021

Groups and Cohorts

Group/Cohort
Patients; Subjects with unipolar depression
Healthy; Healthy Control Group

Outcome Measures

Primary Outcome Measures :

1. Change in Retinal nerve fiber layer thickness [ Time Frame: 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 :

1. Choroid thickness [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

First-episode major depressive outpatients or inpatients followed up in Psychiatry Department of Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital, and healthy volunteers matched with them in terms of age and gender for comparison will be included in the study.

Criteria

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

Contacts and Locations

Locations

Turkey

Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital

Diyarbakır, Turkey, 21070

Sponsors and Collaborators

Mehmet Diyaddin Güleken

More Information

• Responsible Party: Mehmet Diyaddin Güleken, Medical Doctor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04717921
• Other Study ID Numbers: Mehmet Diyaddin Güleken
• First Posted: January 22, 2021
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital:

unipolar depression; optical coherence tomography; retinal nerve fiber layer; selective serotonin reuptake inhibitor

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders