DepressionNCT04305132
Effect of Electroconvulsive Therapy on Retinal Nerve Fiber Layer Thickness in Depression
An observational study of Depression, run by Mehmet Diyaddin Güleken at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Electroconvulsive therapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Tranining and Research Hospital
Diyarbakır, 21070
Mehmet D Güleken, MD, +905063282603, mdguleken@hotmail.com
About this study
Official title: Can Electroconvulsive Therapy Alter Retinal Nerve Fiber Layer Thickness of Patients With Depression
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.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Electroconvulsive therapy
- Keywords
- depression, electroconvulsive therapy, retinal nerve fiber layer, optical coherence tomography
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
Thymatron System IV electroconvulsive therapy device
| Study group | Role | What they receive |
|---|---|---|
| Depression | Subjects with depression treated with electroconvulsive therapy Receives: Device: Electroconvulsive therapy | |
| Healthy | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of retinal nerve fiber layer thickness
Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy
Measured: About 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 50 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
- Investigators
- Mehmet D Güleken, MD, Study director, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305132
- Sponsor's protocol ID
- MDGuleken
- Status last verified
- Jan 2021
- First submitted
- 9 Mar 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 30631748Ousdal 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.
PubMed 31561859Pan 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.
PubMed 30551326Mutlu 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.
PubMed 29946702
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Electroconvulsive Therapy Alter Retinal Nerve Fiber Layer Thickness of Patients With Depression
- ClinicalTrials.gov ID
- NCT04305132
- Acronym / sponsor ID
- MDGuleken
- Conditions
- Depression
- Keywords
- depression, electroconvulsive therapy, retinal nerve fiber layer, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mehmet Diyaddin GülekenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 12 Mar 2020 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression | – | Device: Electroconvulsive therapySubjects with depression treated with electroconvulsive therapy |
| Healthy | – | –Healthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapyThymatron System IV electroconvulsive therapy device | Device | Depression |
Primary outcome
Changes of retinal nerve fiber layer thickness
Time frame: About 4 weeks
Changes of retinal nerve fiber layer thickness of subjects with depression before and after electroconvulsive therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Background: PubMed 30631748Gazdag 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.
- Background: PubMed 31561859Ousdal 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.
- Background: PubMed 30551326Pan 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.
- Background: PubMed 29946702Mutlu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Mehmet D Güleken, MD study director
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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 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 3 inclusion and 5 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 27 Jan 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?
Contact Mehmet D Güleken, MD (+905063282603, mdguleken@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of retinal nerve fiber layer thickness (time frame: About 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305132, which also lists 4 linked publications.
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 27 Jan 2021.