NCT05539131

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

Completed NA Results posted Last updated 11 September 2025

What this trial tests

NA trial testing transcranial direct current stimulation (tDCS) in Depression in 198 participants. Completed in 31 December 2024.

Timeline

4 November 2022

Primary endpoint
31 October 2024

31 December 2024

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	198
Start date	4 November 2022
Primary completion	31 October 2024
Estimated completion	31 December 2024
Sites	5 locations across South Korea

Drugs / interventions tested

• transcranial direct current stimulation (tDCS)

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Yonsei University

Who can join

Adults 19 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	30.27	± 13.22
Sham	29.62	± 11.12

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	24.96	± 13.01
Sham	23.98	± 13.32

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	24.35	± 13.85
Sham	22.09	± 13.66

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	22.81	± 14.9
Sham	20.49	± 14.46

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

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	25.63	± 8.15
Sham	24.29	± 7.71

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	19.76	± 8.40
Sham	19.43	± 8.79

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	19.15	± 9.26
Sham	18.42	± 10.91

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	19.30	± 10.35
Sham	17.13	± 12.95

Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 Secondary · From Visit1(baseline) to 91 days

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.

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	36.83	± 17.74
Sham	36.40	± 16.37

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	34.39	± 17.86
Sham	31.53	± 19.15

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	30.73	± 18.42
Sham	26.25	± 19.39

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	27.19	± 18.95
Sham	23.84	± 19.06

Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 Secondary · From Visit1(baseline) to 91 days

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.

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	16.22	± 9.01
Sham	17.44	± 7.67

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	13.18	± 8.07
Sham	14.62	± 9.09

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	13.70	± 9.49
Sham	13.11	± 8.70

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	12.92	± 8.99
Sham	13.15	± 10.48

Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 Secondary · From Visit1(baseline) to 91 days

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

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	3.19	± 1.01
Sham	3.35	± 0.89

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	2.87	± 0.94
Sham	3.04	± 1.02

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	2.74	± 1.04
Sham	2.95	± 1.11

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	2.75	± 1.11
Sham	2.75	± 1.13

Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 Secondary · From Visit1(baseline) to 91 days

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.

Visit1(Baseline)

Group	Value	95% CI
Active (Real)	42.39	± 11.45
Sham	42.09	± 11.12

Visit2(18~24 days from the baseline)

Group	Value	95% CI
Active (Real)	46.58	± 11.39
Sham	46.78	± 9.98

Visit3(39~45 days from the baseline)

Group	Value	95% CI
Active (Real)	48.83	± 11.67
Sham	48.95	± 10.59

Visit4(77~91 days from the baseline)

Group	Value	95% CI
Active (Real)	49.51	± 12.10
Sham	48.09	± 10.54

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active

Serious: 2/108 (2%)

Deaths: 0/108

Sham(1)

Serious: 0/89 (0%)

Deaths: 0/89

Sham(2)

Serious: 0/89 (0%)

Deaths: 0/89

Serious adverse events (1 terms)

Reaction	System	Active	Sham(1)	Sham(2)
Depression	Psychiatric disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Active	Sham(1)	Sham(2)
Skin irriation	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Depression.

Data from ClinicalTrials.gov NCT05539131 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols.
   Park HY, Park J, Roh D, Jhung K, et al · · 2025 · cited 1× · PMID 41376187 · DOI 10.1002/brb3.71119
2. Identifying treatment response classes to transcranial direct current stimulation from daily ecological momentary assessment patterns in patients with depression.
   Jung HW, Park S, Chung K, Kim Y, et al · · 2026 · PMID 41967000 · DOI 10.1093/ijnp/pyag012