DepressionNCT05539131

Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

A study testing transcranial direct current stimulation (tDCS) in people with Depression, run by Yonsei University at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology. Read more about this study

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Depression
What is being tested?: transcranial direct current stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 198 participants
Where: 5 sitesSouth Korea
Study dates: 4 Nov 2022to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Who cannot join

Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Korea5 sites

Hallym Univsity Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
National Health Insurance Service Ilsanhospital
Goyang-si, Gyeonggi-do, 10444
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Catholic Kwandong University International St. Mary'S Hospital
Incheon, Gyeonggi-do, 22711
Yongin Severance Hospital, Yonsei University College of Medicine
Yongin, Gyeonggi-do, 16995

Other trials in South Korea

About this study

Official title: Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields

Read the detailed description

As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

Conditions: Depression
Being tested: transcranial direct current stimulation (tDCS)
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial direct current stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.

Study groups in NCT05539131
Study group	Role	What they receive
active transcranial direct current stimulation (tDCS)	Active comparator	daily active transcranial direct current stimulation (tDCS) use for 6 weeks Receives: Device: transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation (tDCS)	Sham comparator	daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks Receives: Device: transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question.
0~13: Minimal 14~19: Mild depression 20~28: Moderate depression 29~63: Severe depression
Measured: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question.
The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression
Measured: From Visit1(baseline) to 91 days

Secondary outcomes (4)

Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Epidemiologic Studies Depression Scale Revised test was revised to reflect the major depressive illustration diagnostic criteria for the evaluation of depression. Items reflecting anaesthesia, mental exercise delay/anxiety, and suicide accidents have been added, and are measured as 0 to 4 points per question on a self-report 20 question scale. The score ranges from 0~80 points. . A score equal to or above 16 indicates a person at risk for clinical depression.
Measured: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
The scale developed by Hamilton consists of 14 questions, and is evaluated by the clinician on a 5-point Likert scale of a semi-structured interview tool. The score ranges from 0~56 points. Each item is scored on a scale of 0 (not present) to 4 (severe), with total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease.
It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. The score ranges from 0~7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill
Measured: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
t is possible to measure high-dimensional cognitive functions such as perceptual organization ability and visual movement coordination, and examine attentional concentration, visual short-term memory, and mental movement speed. A post-marketing survey (PMS) on a new mechanism of anti-depressant (vortioxetine) is used to measure cognitive function before and after the use of the antidepressant in depressed patients. The score is the number of correct number-symbol matches achieved in 90 s. The score ranges from 0~93 points.
Measured: From Visit1(baseline) to 91 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 202231 Dec 2024

First posted14 Sep 2022
Study start4 Nov 2022
Primary completion31 Oct 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05539131
Sponsor's protocol ID: 2022-0225-002
Status last verified: Sep 2025
First submitted: 8 Sep 2022
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Personal information collected for research purposes shall be kept anonymously in a safe place within the institute to be managed so that personal information is not exposed.

Publications

Oh J, Jang KI, Jeon S, Chae JH. Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2022 Feb 28;20(1):87-96. doi: 10.9758/cpn.2022.20.1.87.
PubMed 35078951
Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.
PubMed 25983531
Wang J, Luo H, Schulke R, Geng X, Sahakian BJ, Wang S. Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. BMC Med. 2021 Dec 17;19(1):319. doi: 10.1186/s12916-021-02181-4.
PubMed 34915885
Ahn JS, Kim WJ, Jhung K, Roh D, Park J, Park JY. Dissociable roles of frontal electroencephalography markers in depression: Predictive value of frontal alpha asymmetry and responsive changes in beta power following home-based brain stimulation. J Psychiatr Res. 2026 Oct;201:254-264. doi: 10.1016/j.jpsychires.2026.06.030. Epub 2026 Jun 23.
PubMed 42341411
Jung HW, Park S, Chung K, Kim Y, Roh D, Jhung K, Kim WJ, Park JY, Park J. Identifying treatment response classes to transcranial direct current stimulation from daily ecological momentary assessment patterns in patients with depression. Int J Neuropsychopharmacol. 2026 Apr 6;29(4):pyag012. doi: 10.1093/ijnp/pyag012.
PubMed 41967000
Park HY, Park J, Roh D, Jhung K, Chang JG, Park S, Ryu JS, Do G, Lee K, Park JY, Kim WJ. Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols. Brain Behav. 2025 Dec;15(12):e71119. doi: 10.1002/brb3.71119.
PubMed 41376187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields
ClinicalTrials.gov ID: NCT05539131
Acronym / sponsor ID: 2022-0225-002
Conditions: Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 4 Nov 2022 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 14 Sep 2022 (actual)
Results: Posted 11 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
active transcranial direct current stimulation (tDCS)	Active comparator	Device: transcranial direct current stimulation (tDCS)daily active transcranial direct current stimulation (tDCS) use for 6 weeks
sham transcranial direct current stimulation (tDCS)	Sham comparator	Device: transcranial direct current stimulation (tDCS)daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Key exclusion criteria (1 listed)

Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

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
transcranial direct current stimulation (tDCS)Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.	Device	active transcranial direct current stimulation (tDCS), sham transcranial direct current stimulation (tDCS)

Primary outcome

Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
Time frame: From Visit1(baseline) to 91 days
It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0~13: Minimal 14~19: Mild depression 20~28: Moderate depression 29~63: Severe depression
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
Time frame: From Visit1(baseline) to 91 days
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression

4 secondary outcomes

Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Time frame: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
Time frame: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
Time frame: From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
Time frame: From Visit1(baseline) to 91 days

Results and safety

Results posted to the registry on 11 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active (Real)	108	89
Sham	89	57

Primary outcome: Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13

Time frame: From Visit1(baseline) to 91 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Active (Real) n = 108	Sham n = 89
Visit1(Baseline)	30.27 (13.22)	29.62 (11.12)
Visit2(18~24 days from the baseline)	24.96 (13.01)	23.98 (13.32)
Visit3(39~45 days from the baseline)	24.35 (13.85)	22.09 (13.66)
Visit4(77~91 days from the baseline)	22.81 (14.9)	20.49 (14.46)

Active (Real) vs Sham: p = 0.862, Mixed Models Analysis

Population analysed: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).

Primary outcome: Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13

Time frame: From Visit1(baseline) to 91 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Active (Real) n = 108	Sham n = 89
Visit1(Baseline)	25.63 (8.15)	24.29 (7.71)
Visit2(18~24 days from the baseline)	19.76 (8.40)	19.43 (8.79)
Visit3(39~45 days from the baseline)	19.15 (9.26)	18.42 (10.91)
Visit4(77~91 days from the baseline)	19.30 (10.35)	17.13 (12.95)

Active (Real) vs Sham: p = 0.662, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were systematically collected over a mean of 13 weeks during the 6-week intervention period and the follow-up visit immediately following the end of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	2 of 108 (1.9%)	3 of 108 (2.8%)	0 of 108
Sham(1)	0 of 89 (0%)	5 of 89 (5.6%)	0 of 89
Sham(2)	0 of 89 (0%)	1 of 89 (1.1%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35078951Oh J, Jang KI, Jeon S, Chae JH. Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2022 Feb 28;20(1):87-96. doi: 10.9758/cpn.2022.20.1.87.
Background: PubMed 25983531Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.
Background: PubMed 34915885Wang J, Luo H, Schulke R, Geng X, Sahakian BJ, Wang S. Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. BMC Med. 2021 Dec 17;19(1):319. doi: 10.1186/s12916-021-02181-4.
Derived from this study: PubMed 42341411Ahn JS, Kim WJ, Jhung K, Roh D, Park J, Park JY. Dissociable roles of frontal electroencephalography markers in depression: Predictive value of frontal alpha asymmetry and responsive changes in beta power following home-based brain stimulation. J Psychiatr Res. 2026 Oct;201:254-264. doi: 10.1016/j.jpsychires.2026.06.030. Epub 2026 Jun 23.
Derived from this study: PubMed 41967000Jung HW, Park S, Chung K, Kim Y, Roh D, Jhung K, Kim WJ, Park JY, Park J. Identifying treatment response classes to transcranial direct current stimulation from daily ecological momentary assessment patterns in patients with depression. Int J Neuropsychopharmacol. 2026 Apr 6;29(4):pyag012. doi: 10.1093/ijnp/pyag012.
Derived from this study: PubMed 41376187Park HY, Park J, Roh D, Jhung K, Chang JG, Park S, Ryu JS, Do G, Lee K, Park JY, Kim WJ. Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols. Brain Behav. 2025 Dec;15(12):e71119. doi: 10.1002/brb3.71119.
Individual participant dataSharing planned: Yes. Personal information collected for research purposes shall be kept anonymously in a safe place within the institute to be managed so that personal information is not exposed.

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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.

Woo Jung Kim principal investigator

Severance Hospital

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation (tDCS) in people with Depression, run by Yonsei University at 5 sites in South Korea.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 (time frame: From Visit1(baseline) to 91 days). The study lists 2 primary outcomes in all. 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 NCT05539131, which also lists 6 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 11 Sep 2025.