Trial Outcomes & Findings for Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients (NCT NCT05539131)
NCT ID: NCT05539131
Last Updated: 2025-09-11
Results Overview
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
COMPLETED
NA
198 participants
From Visit1(baseline) to 91 days
2025-09-11
Participant Flow
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).
Participant milestones
| Measure |
Active (Real)
Participants received 6 weeks of active transcranial direct current stimulation (tDCS) at 2 mA, 5 days per week.
|
Sham
Participants received 3 weeks of active tDCS followed by 3 weeks of sham stimulation (placebo control).
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
89
|
|
Overall Study
COMPLETED
|
89
|
57
|
|
Overall Study
NOT COMPLETED
|
19
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients
Baseline characteristics by cohort
| Measure |
Active (Real)
n=108 Participants
Participants received 6 weeks of active transcranial direct current stimulation (tDCS) treatment at 2 mA, 5 days per week.
|
Sham
n=89 Participants
Participants received 3 weeks of active tDCS treatment followed by 3 weeks of sham stimulation (placebo control).
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
108 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
108 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
108 participants
n=5 Participants
|
89 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Beck Depression Inventory-II(BDI-II)
|
30.27 units on a scale
STANDARD_DEVIATION 13.22 • n=5 Participants
|
29.62 units on a scale
STANDARD_DEVIATION 11.12 • n=7 Participants
|
30.00 units on a scale
STANDARD_DEVIATION 12.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
Visit1(Baseline)
|
30.27 units on a scale
Standard Deviation 13.22
|
29.62 units on a scale
Standard Deviation 11.12
|
|
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
Visit2(18~24 days from the baseline)
|
24.96 units on a scale
Standard Deviation 13.01
|
23.98 units on a scale
Standard Deviation 13.32
|
|
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
Visit4(77~91 days from the baseline)
|
22.81 units on a scale
Standard Deviation 14.9
|
20.49 units on a scale
Standard Deviation 14.46
|
|
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
Visit3(39~45 days from the baseline)
|
24.35 units on a scale
Standard Deviation 13.85
|
22.09 units on a scale
Standard Deviation 13.66
|
PRIMARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
Visit1(Baseline)
|
25.63 units on a scale
Standard Deviation 8.15
|
24.29 units on a scale
Standard Deviation 7.71
|
|
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
Visit2(18~24 days from the baseline)
|
19.76 units on a scale
Standard Deviation 8.40
|
19.43 units on a scale
Standard Deviation 8.79
|
|
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
Visit3(39~45 days from the baseline)
|
19.15 units on a scale
Standard Deviation 9.26
|
18.42 units on a scale
Standard Deviation 10.91
|
|
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
Visit4(77~91 days from the baseline)
|
19.30 units on a scale
Standard Deviation 10.35
|
17.13 units on a scale
Standard Deviation 12.95
|
SECONDARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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.
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Visit1(Baseline)
|
36.83 units on a scale
Standard Deviation 17.74
|
36.40 units on a scale
Standard Deviation 16.37
|
|
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Visit2(18~24 days from the baseline)
|
34.39 units on a scale
Standard Deviation 17.86
|
31.53 units on a scale
Standard Deviation 19.15
|
|
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Visit3(39~45 days from the baseline)
|
30.73 units on a scale
Standard Deviation 18.42
|
26.25 units on a scale
Standard Deviation 19.39
|
|
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13
Visit4(77~91 days from the baseline)
|
27.19 units on a scale
Standard Deviation 18.95
|
23.84 units on a scale
Standard Deviation 19.06
|
SECONDARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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.
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
Visit1(Baseline)
|
16.22 units on a scale
Standard Deviation 9.01
|
17.44 units on a scale
Standard Deviation 7.67
|
|
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
Visit2(18~24 days from the baseline)
|
13.18 units on a scale
Standard Deviation 8.07
|
14.62 units on a scale
Standard Deviation 9.09
|
|
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
Visit3(39~45 days from the baseline)
|
13.70 units on a scale
Standard Deviation 9.49
|
13.11 units on a scale
Standard Deviation 8.70
|
|
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13
Visit4(77~91 days from the baseline)
|
12.92 units on a scale
Standard Deviation 8.99
|
13.15 units on a scale
Standard Deviation 10.48
|
SECONDARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
Visit1(Baseline)
|
3.19 units on a scale
Standard Deviation 1.01
|
3.35 units on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
Visit2(18~24 days from the baseline)
|
2.87 units on a scale
Standard Deviation 0.94
|
3.04 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
Visit3(39~45 days from the baseline)
|
2.74 units on a scale
Standard Deviation 1.04
|
2.95 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13
Visit4(77~91 days from the baseline)
|
2.75 units on a scale
Standard Deviation 1.11
|
2.75 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: From Visit1(baseline) to 91 daysPopulation: 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).
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.
Outcome measures
| Measure |
Active (Real)
n=108 Participants
6WA, 6-week active stimulation.
|
Sham
n=89 Participants
3WA, 3-week active followed by 3-week sham stimulation.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
Visit1(Baseline)
|
42.39 units on a scale
Standard Deviation 11.45
|
42.09 units on a scale
Standard Deviation 11.12
|
|
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
Visit2(18~24 days from the baseline)
|
46.58 units on a scale
Standard Deviation 11.39
|
46.78 units on a scale
Standard Deviation 9.98
|
|
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
Visit3(39~45 days from the baseline)
|
48.83 units on a scale
Standard Deviation 11.67
|
48.95 units on a scale
Standard Deviation 10.59
|
|
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13
Visit4(77~91 days from the baseline)
|
49.51 units on a scale
Standard Deviation 12.10
|
48.09 units on a scale
Standard Deviation 10.54
|
Adverse Events
Active
Sham(1)
Sham(2)
Serious adverse events
| Measure |
Active
n=108 participants at risk
6WA, 6-week active stimulation.
|
Sham(1)
n=89 participants at risk
3-week active followed
|
Sham(2)
n=89 participants at risk
3-week sham stimulation.
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
1.9%
2/108 • Number of events 2 • 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.
|
0.00%
0/89 • 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.
|
0.00%
0/89 • 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.
|
Other adverse events
| Measure |
Active
n=108 participants at risk
6WA, 6-week active stimulation.
|
Sham(1)
n=89 participants at risk
3-week active followed
|
Sham(2)
n=89 participants at risk
3-week sham stimulation.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irriation
|
2.8%
3/108 • Number of events 3 • 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.
|
5.6%
5/89 • Number of events 5 • 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.
|
1.1%
1/89 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place