N/A
N=197
Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients
Depression
Bottom Line
View on ClinicalTrials.gov: NCT05539131 ↗Enrolled (actual)
197
Serious AEs
0.7%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 — 30.27; 29.62; 24.96; 23.98 units on a scale — p=0.862
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Yonsei University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 |
30.27; 29.62; 24.96; 23.98; 24.35; 22.09 | 0.862 |
| PRIMARY Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 |
25.63; 24.29; 19.76; 19.43; 19.15; 18.42 | 0.662 |
| SECONDARY Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 |
36.83; 36.40; 34.39; 31.53; 30.73; 26.25 | 0.318 |
| SECONDARY Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 |
16.22; 17.44; 13.18; 14.62; 13.70; 13.11 | 0.273 |
| SECONDARY Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 |
3.19; 3.35; 2.87; 3.04; 2.74; 2.95 | 0.639 |
| SECONDARY Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 |
42.39; 42.09; 46.58; 46.78; 48.83; 48.95 | 0.452 |
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.
Eligibility Criteria
Inclusion Criteria
- Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05539131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.