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| Name | Class |
|---|---|
| Ybrain Inc. | INDUSTRY |
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In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham tDCS treatment group | Sham Comparator | the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes |
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| active tDCS treatment group | Experimental | 2mA of current was delivered during the 30 minutes of treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS treatment | Device | Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week). |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms | Change from Baseline Hamilton Depression Scale at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI) | The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms. | Weeks 0, 2, 4, and 6 |
| Montgomery-Asberg Depression Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | 06591 | 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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| Antidepressant Drug(escitalopram) | Drug | Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment. |
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Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. |
| Weeks 0, 2, 4, and 6 |
| Beck Anxiety Inventory | Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The overall score ranges from 0 to 63. | Weeks 0, 2, 4, and 6 |