Unipolar DepressionNCT04717921
Assesment of Retinal Nerve Fiber Layer in First Episode Depressive Patients Using Selective Serotonin Reuptake Inhibitor
An observational study of Unipolar Depression, run by Mehmet Diyaddin Güleken at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unipolar Depression
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital
Diyarbakır, 21070
About this study
Official title: Can Selective Serotonin Reuptake Inhibitor Drugs Alter Retinal Nerve Fiber Layer Thickness in First Episode Depressive Patients?
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.
Read the 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.
- Conditions
- Unipolar Depression
- Keywords
- unipolar depression, optical coherence tomography, retinal nerve fiber layer, selective serotonin reuptake inhibitor
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Subjects with unipolar depression | |
| Healthy | Healthy Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness change during selective serotonin reuptake inhibitor treatment in first attack depressive subjects
Measured: Baseline, at first week and at the 8th week of the treatment
Secondary outcomes (1)
Choroid thickness
Choroid thickness change during selective serotonin reuptake inhibitor treatment in first attack depressive subjects
Measured: Baseline, at first week and at the 8th week of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2020
- Primary completion30 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Diyaddin Güleken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717921
- Sponsor's protocol ID
- Mehmet Diyaddin Güleken
- Status last verified
- Mar 2021
- First submitted
- 17 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Selective Serotonin Reuptake Inhibitor Drugs Alter Retinal Nerve Fiber Layer Thickness in First Episode Depressive Patients?
- ClinicalTrials.gov ID
- NCT04717921
- Acronym / sponsor ID
- Mehmet Diyaddin Güleken
- Conditions
- Unipolar Depression
- Keywords
- unipolar depression, optical coherence tomography, retinal nerve fiber layer, selective serotonin reuptake inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mehmet Diyaddin GülekenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Subjects with unipolar depression |
| Healthy | – | –Healthy Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Choroid thickness
Time frame: Baseline, at first week and at the 8th week of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression, run by Mehmet Diyaddin Güleken at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retinal nerve fiber layer thickness (time frame: Baseline, at first week and at the 8th week of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.