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

Study Overview
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Brief Summary
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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.

Detailed Description
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As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

Official Title
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Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields

Conditions
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Depression

Intervention / Treatment
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* Device: transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active transcranial direct current stimulation (tDCS)<br>daily active transcranial direct current stimulation (tDCS) use for 6 weeks | Device: transcranial direct current stimulation (tDCS)<br>* Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.<br>|
| Sham Comparator: sham transcranial direct current stimulation (tDCS)<br>daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks | Device: transcranial direct current stimulation (tDCS)<br>* Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms on Beck Depression Inventory-II (BDI-II) at week 13 | 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 | Screening Visit, Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) | 
| Change from baseline in depressive symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at week 13 | 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, 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. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression | Screening Visit, Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at week 13 | 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. | Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) | 
| Change from baseline in depressive symptoms on Hamilton Anxiety Scale (HAM-A) at week 13 | 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 a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) | 
| Change from baseline in depressive symptoms on Clinical Global Impression-Severity of Illness scale (CGI-SI) at week 13 | 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 disease. The score ranges from 0 7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill | Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) | 
| Change from baseline in depressive symptoms on Digit Symbol Substitution Test (DSST) at week 13 | 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. | Baseline, 18 24 days from the baseline (Visit 2), 39 45 days from the baseline (Visit 3), 77 91 days from the baseline (Follow-up 1) |