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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Myongji Hospital | OTHER |
| CHA University |
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Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YBand(YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications) |
|
| Sham-Yband(YDT-201N) | Sham Comparator | sham-tDCS application 5 days a week for 2 weeks (total of 10 applications) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yband(YDT-201N) | Device | transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | Measured by Montgomery-Åsberg Depression Rating Scale (MADRS) | from baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment. | At 6 weeks after treatment. |
| Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seungwoo Lee | Ybrain Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ybrain | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| National Health Insurance Service Ilsan Hospital | OTHER |
| Ajou University | OTHER |
| Hallym University Medical Center | OTHER |
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| Sham-Yband(YDT-201N) | Device | transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) |
|
The percentage of subjects whose MADRS score is under 10 in week 6 after treatment. |
| At 6 weeks after treatment |
| Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI) | Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment |
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II) | Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment |
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI) | Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment |