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This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.
During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High real stimulation group | Active Comparator | 2mA tDCS stimulation daily (42 times) for 6 weeks |
|
| Low real stimulation group | Active Comparator | 1mA tDCS stimulation daily (42 times) for 6 weeks |
|
| Sham stimulation group | Sham Comparator | sham stimulation daily (42 times) for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation_High real | Device | Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA). |
| Measure | Description | Time Frame |
|---|---|---|
| Working memory ability evaluation(N-Back tast) | N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function. | Change from Baseline Working memory ability evaluation at 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale | The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The lower the total score, the better the symptoms. | Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks |
| Hamilton Anxiety Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-Hyun Baek | Contact | +82 2-2008-4388 | jh1.baek@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji-Hyun Baek | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39809704 | Derived | Lee CW, Park K, Ahn JE, Jang Y, Park YS, Yu H, Lee D, Ihm HK, Lee J, Kim J, Lee YI, Lim SE, Kwon SS, Park HY, Ha TH, Yoon IY, Myung W, Baek JH. Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial. Eur Psychiatry. 2025 Jan 15;68(1):e15. doi: 10.1192/j.eurpsy.2024.1811. |
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| Transcranial direct current stimulation_Low real | Device | Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA). |
|
| Transcranial direct current stimulation_Sham | Device | Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA). |
|
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.The lower the total score, the better the symptoms. |
| Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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