Depression
Conditions
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | From Visit1(baseline) to 91 days | 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 |
| Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | From Visit1(baseline) to 91 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | From Visit1(baseline) to 91 days | 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. |
| Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | From Visit1(baseline) to 91 days | 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 total score range of 0-56, where \<17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. |
| Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | From Visit1(baseline) to 91 days | 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 |
| Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | From Visit1(baseline) to 91 days | 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. |
Countries
South Korea
Participant flow
Pre-assignment details
Before assignment to study arms, 12 participants were excluded during the screening phase due to failure to meet eligibility criteria (e.g., comorbid psychiatric conditions or contraindications to tDCS).
Participants by arm
| Arm | Count |
|---|---|
| Active (Real) Participants received 6 weeks of active transcranial direct current stimulation (tDCS) treatment at 2 mA, 5 days per week. | 108 |
| Sham Participants received 3 weeks of active tDCS treatment followed by 3 weeks of sham stimulation (placebo control). | 89 |
| Total | 197 |
Baseline characteristics
| Characteristic | Active (Real) | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 108 Participants | 89 Participants | 197 Participants |
| Beck Depression Inventory-II(BDI-II) | 30.27 units on a scale STANDARD_DEVIATION 13.22 | 29.62 units on a scale STANDARD_DEVIATION 11.12 | 30.00 units on a scale STANDARD_DEVIATION 12.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 108 Participants | 89 Participants | 197 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 108 participants | 89 participants | 197 participants |
| Sex: Female, Male Female | 73 Participants | 51 Participants | 124 Participants |
| Sex: Female, Male Male | 35 Participants | 38 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 89 | 0 / 89 |
| other Total, other adverse events | 3 / 108 | 5 / 89 | 1 / 89 |
| serious Total, serious adverse events | 2 / 108 | 0 / 89 | 0 / 89 |
Outcome results
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
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit1(Baseline) | 30.27 units on a scale | Standard Deviation 13.22 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit2(18~24 days from the baseline) | 24.96 units on a scale | Standard Deviation 13.01 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit3(39~45 days from the baseline) | 24.35 units on a scale | Standard Deviation 13.85 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit4(77~91 days from the baseline) | 22.81 units on a scale | Standard Deviation 14.9 |
| Sham | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit4(77~91 days from the baseline) | 20.49 units on a scale | Standard Deviation 14.46 |
| Sham | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit1(Baseline) | 29.62 units on a scale | Standard Deviation 11.12 |
| Sham | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit3(39~45 days from the baseline) | 22.09 units on a scale | Standard Deviation 13.66 |
| Sham | Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13 | Visit2(18~24 days from the baseline) | 23.98 units on a scale | Standard Deviation 13.32 |
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
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit1(Baseline) | 25.63 units on a scale | Standard Deviation 8.15 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit2(18~24 days from the baseline) | 19.76 units on a scale | Standard Deviation 8.4 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit3(39~45 days from the baseline) | 19.15 units on a scale | Standard Deviation 9.26 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit4(77~91 days from the baseline) | 19.30 units on a scale | Standard Deviation 10.35 |
| Sham | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit4(77~91 days from the baseline) | 17.13 units on a scale | Standard Deviation 12.95 |
| Sham | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit1(Baseline) | 24.29 units on a scale | Standard Deviation 7.71 |
| Sham | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit3(39~45 days from the baseline) | 18.42 units on a scale | Standard Deviation 10.91 |
| Sham | Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13 | Visit2(18~24 days from the baseline) | 19.43 units on a scale | Standard Deviation 8.79 |
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
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit1(Baseline) | 3.19 units on a scale | Standard Deviation 1.01 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit2(18~24 days from the baseline) | 2.87 units on a scale | Standard Deviation 0.94 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit3(39~45 days from the baseline) | 2.74 units on a scale | Standard Deviation 1.04 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit4(77~91 days from the baseline) | 2.75 units on a scale | Standard Deviation 1.11 |
| Sham | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit4(77~91 days from the baseline) | 2.75 units on a scale | Standard Deviation 1.13 |
| Sham | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit1(Baseline) | 3.35 units on a scale | Standard Deviation 0.89 |
| Sham | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit3(39~45 days from the baseline) | 2.95 units on a scale | Standard Deviation 1.11 |
| Sham | Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13 | Visit2(18~24 days from the baseline) | 3.04 units on a scale | Standard Deviation 1.02 |
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.
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit1(Baseline) | 42.39 units on a scale | Standard Deviation 11.45 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit2(18~24 days from the baseline) | 46.58 units on a scale | Standard Deviation 11.39 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit3(39~45 days from the baseline) | 48.83 units on a scale | Standard Deviation 11.67 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit4(77~91 days from the baseline) | 49.51 units on a scale | Standard Deviation 12.1 |
| Sham | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit4(77~91 days from the baseline) | 48.09 units on a scale | Standard Deviation 10.54 |
| Sham | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit1(Baseline) | 42.09 units on a scale | Standard Deviation 11.12 |
| Sham | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit3(39~45 days from the baseline) | 48.95 units on a scale | Standard Deviation 10.59 |
| Sham | Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13 | Visit2(18~24 days from the baseline) | 46.78 units on a scale | Standard Deviation 9.98 |
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.
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit1(Baseline) | 36.83 units on a scale | Standard Deviation 17.74 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit2(18~24 days from the baseline) | 34.39 units on a scale | Standard Deviation 17.86 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit3(39~45 days from the baseline) | 30.73 units on a scale | Standard Deviation 18.42 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit4(77~91 days from the baseline) | 27.19 units on a scale | Standard Deviation 18.95 |
| Sham | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit4(77~91 days from the baseline) | 23.84 units on a scale | Standard Deviation 19.06 |
| Sham | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit1(Baseline) | 36.40 units on a scale | Standard Deviation 16.37 |
| Sham | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit3(39~45 days from the baseline) | 26.25 units on a scale | Standard Deviation 19.39 |
| Sham | Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13 | Visit2(18~24 days from the baseline) | 31.53 units on a scale | Standard Deviation 19.15 |
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 total score range of 0-56, where \<17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: From Visit1(baseline) to 91 days
Population: Eligible individuals were adults aged 19-65 years with a primary diagnosis of mild to moderate MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (Association, 2013) and confirmed using the Mini International Neuropsychiatric Interview (Sheehan et al., 1998).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active (Real) | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit1(Baseline) | 16.22 units on a scale | Standard Deviation 9.01 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit2(18~24 days from the baseline) | 13.18 units on a scale | Standard Deviation 8.07 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit3(39~45 days from the baseline) | 13.70 units on a scale | Standard Deviation 9.49 |
| Active (Real) | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit4(77~91 days from the baseline) | 12.92 units on a scale | Standard Deviation 8.99 |
| Sham | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit4(77~91 days from the baseline) | 13.15 units on a scale | Standard Deviation 10.48 |
| Sham | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit1(Baseline) | 17.44 units on a scale | Standard Deviation 7.67 |
| Sham | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit3(39~45 days from the baseline) | 13.11 units on a scale | Standard Deviation 8.7 |
| Sham | Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13 | Visit2(18~24 days from the baseline) | 14.62 units on a scale | Standard Deviation 9.09 |