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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active transcranial direct current stimulation (tDCS) | Active Comparator | daily active transcranial direct current stimulation (tDCS) use for 6 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From Visit1(baseline) to 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Jung Kim | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym Univsity Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 24253 | South Korea | ||
| National Health Insurance Service Ilsanhospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35078951 | Background | 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. | |
| 25983531 | Background | 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. |
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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.
After the completion of the study, the data will be available for 3 years.
For data security, encrypted communication methods will be used and restricted access to only authorized licensed personnel on the e-CRF domain.
Before assignment to study arms, 12 participants were excluded during the screening phase due to failure to meet eligibility criteria (e.g., comorbid psychiatric conditions or contraindications to tDCS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active (Real) | Participants received 6 weeks of active transcranial direct current stimulation (tDCS) at 2 mA, 5 days per week. |
| FG001 | Sham | Participants received 3 weeks of active tDCS followed by 3 weeks of sham stimulation (placebo control). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Active (Real) | Participants received 6 weeks of active transcranial direct current stimulation (tDCS) treatment at 2 mA, 5 days per week. |
| BG001 | Sham | Participants received 3 weeks of active tDCS treatment followed by 3 weeks of sham stimulation (placebo control). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
|
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.
Adverse event information was collected using systematic assessments, including standardized questionnaires, regular investigator assessments, and participant self-reports during study visits. The definition of adverse events aligns with clinicaltrials.gov guidelines, focusing on events temporally associated with study participation, regardless of causality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | 6WA, 6-week active stimulation. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irriation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Woo Jung Kim | Yongin Severance Hospital | 01092827943 | woojungkim@yuhs.ac |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2023 | May 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. | 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 | 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. | From Visit1(baseline) to 91 days |
| Goyang-si |
| Gyeonggi-do |
| 10444 |
| South Korea |
| Myongji Hospital | Goyang-si | Gyeonggi-do | 10475 | South Korea |
| Catholic Kwandong University International St. Mary'S Hospital | Incheon | Gyeonggi-do | 22711 | South Korea |
| Yongin Severance Hospital, Yonsei University College of Medicine | Yongin | Gyeonggi-do | 16995 | South Korea |
| 34915885 | Background | 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. |
| 42341411 | Derived | 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 Jun 23;201:254-264. doi: 10.1016/j.jpsychires.2026.06.030. Online ahead of print. |
| 41967000 | Derived | 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. |
| 41376187 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beck Depression Inventory-II(BDI-II) | 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 | Mean | Standard Deviation | units on a scale |
|
| OG001 | Sham | 3WA, 3-week active followed by 3-week sham stimulation. |
|
|
|
| Primary | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
|
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|
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
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| Secondary | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | From Visit1(baseline) to 91 days |
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| 108 |
| 2 |
| 108 |
| 3 |
| 108 |
| EG001 | Sham(1) | 3-week active followed | 0 | 89 | 0 | 89 | 5 | 89 |
| EG002 | Sham(2) | 3-week sham stimulation. | 0 | 89 | 0 | 89 | 1 | 89 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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| Visit4(77~91 days from the baseline) |
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