An interventional study of transcranial direct current stimulation (tDCS) in Depression, sponsored by Yonsei University. Completed at 5 sites in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 198 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
daily active transcranial direct current stimulation (tDCS) use for 6 weeks
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
Device: 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.
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
Time frame: 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
Time frame: From Visit1(baseline) to 91 days
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.
Time frame: 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.
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
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
Time frame: 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.
Time frame: From Visit1(baseline) to 91 days
| Milestone | Active (Real) | Sham |
|---|---|---|
| Started | 108 | 89 |
| Completed | 89 | 57 |
| Not completed | 19 | 32 |
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
| units on a scale | Active (Real) | Sham |
|---|---|---|
| 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 |
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
| units on a scale | Active (Real) | Sham |
|---|---|---|
| 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 |
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.
| units on a scale | Active (Real) | Sham |
|---|---|---|
| Visit1(Baseline) | 36.83 ± 17.74 | 36.40 ± 16.37 |
| Visit2(18~24 days from the baseline) | 34.39 ± 17.86 | 31.53 ± 19.15 |
| Visit3(39~45 days from the baseline) | 30.73 ± 18.42 | 26.25 ± 19.39 |
| Visit4(77~91 days from the baseline) | 27.19 ± 18.95 | 23.84 ± 19.06 |
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.
| units on a scale | Active (Real) | Sham |
|---|---|---|
| Visit1(Baseline) | 16.22 ± 9.01 | 17.44 ± 7.67 |
| Visit2(18~24 days from the baseline) | 13.18 ± 8.07 | 14.62 ± 9.09 |
| Visit3(39~45 days from the baseline) | 13.70 ± 9.49 | 13.11 ± 8.70 |
| Visit4(77~91 days from the baseline) | 12.92 ± 8.99 | 13.15 ± 10.48 |
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
| units on a scale | Active (Real) | Sham |
|---|---|---|
| Visit1(Baseline) | 3.19 ± 1.01 | 3.35 ± 0.89 |
| Visit2(18~24 days from the baseline) | 2.87 ± 0.94 | 3.04 ± 1.02 |
| Visit3(39~45 days from the baseline) | 2.74 ± 1.04 | 2.95 ± 1.11 |
| Visit4(77~91 days from the baseline) | 2.75 ± 1.11 | 2.75 ± 1.13 |
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.
| units on a scale | Active (Real) | Sham |
|---|---|---|
| Visit1(Baseline) | 42.39 ± 11.45 | 42.09 ± 11.12 |
| Visit2(18~24 days from the baseline) | 46.58 ± 11.39 | 46.78 ± 9.98 |
| Visit3(39~45 days from the baseline) | 48.83 ± 11.67 | 48.95 ± 10.59 |
| Visit4(77~91 days from the baseline) | 49.51 ± 12.10 | 48.09 ± 10.54 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/108 (0%) | 2/108 (1.9%) | 3/108 (2.8%) |
| Sham(1) | 0/89 (0%) | 0/89 (0%) | 5/89 (5.6%) |
| Sham(2) | 0/89 (0%) | 0/89 (0%) | 1/89 (1.1%) |
| Event | Active | Sham(1) | Sham(2) |
|---|---|---|---|
| DepressionPsychiatric disorders | 2/108 | 0/89 | 0/89 |
| Event | Active | Sham(1) | Sham(2) |
|---|---|---|---|
| Skin irriationSkin and subcutaneous tissue disorders | 3/108 | 5/89 | 1/89 |
Active (Real) tDCS Group: Participants received 6 weeks of active transcranial direct current stimulation (tDCS) treatment at 2 mA, 5 days per week. Sham tDCS Group: Participants received 3 weeks of active tDCS treatment followed by 3 weeks of sham stimulation (placebo control).
| Age, Categorical(Participants) | Active (Real) | Sham | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 108 | 89 | 197 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active (Real) | Sham | Total |
|---|---|---|---|
| Female | 73 | 51 | 124 |
| Male | 35 | 38 | 73 |
| Race (NIH/OMB)(Participants) | Active (Real) | Sham | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 108 | 89 | 197 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active (Real) | Sham | Total |
|---|---|---|---|
| South Korea | 108 | 89 | 197 |
| Beck Depression Inventory-II(BDI-II)(units on a scale) | Active (Real) | Sham | Total |
|---|---|---|---|
| Mean | 30.27 ± 13.22 | 29.62 ± 11.12 | 30.00 ± 12.35 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Yonsei University