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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539131
Enrollment
198
Registered
2022-09-14
Start date
2022-11-04
Completion date
2024-12-31
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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

DEVICEtranscranial direct current stimulation (tDCS)

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

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13From Visit1(baseline) to 91 daysIt 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 13From Visit1(baseline) to 91 daysIt 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

MeasureTime frameDescription
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13From Visit1(baseline) to 91 daysEpidemiologic 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 13From Visit1(baseline) to 91 daysThe 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 13From Visit1(baseline) to 91 daysIt 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 13From Visit1(baseline) to 91 dayst 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

ArmCount
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
Total197

Baseline characteristics

CharacteristicActive (Real)ShamTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
108 Participants89 Participants197 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
108 Participants89 Participants197 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
108 participants89 participants197 participants
Sex: Female, Male
Female
73 Participants51 Participants124 Participants
Sex: Female, Male
Male
35 Participants38 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1080 / 890 / 89
other
Total, other adverse events
3 / 1085 / 891 / 89
serious
Total, serious adverse events
2 / 1080 / 890 / 89

Outcome results

Primary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit1(Baseline)30.27 units on a scaleStandard Deviation 13.22
Active (Real)Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit2(18~24 days from the baseline)24.96 units on a scaleStandard Deviation 13.01
Active (Real)Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit3(39~45 days from the baseline)24.35 units on a scaleStandard Deviation 13.85
Active (Real)Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit4(77~91 days from the baseline)22.81 units on a scaleStandard Deviation 14.9
ShamChange From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit4(77~91 days from the baseline)20.49 units on a scaleStandard Deviation 14.46
ShamChange From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit1(Baseline)29.62 units on a scaleStandard Deviation 11.12
ShamChange From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit3(39~45 days from the baseline)22.09 units on a scaleStandard Deviation 13.66
ShamChange From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13Visit2(18~24 days from the baseline)23.98 units on a scaleStandard Deviation 13.32
p-value: 0.862Mixed Models Analysis
Primary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit1(Baseline)25.63 units on a scaleStandard Deviation 8.15
Active (Real)Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit2(18~24 days from the baseline)19.76 units on a scaleStandard Deviation 8.4
Active (Real)Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit3(39~45 days from the baseline)19.15 units on a scaleStandard Deviation 9.26
Active (Real)Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit4(77~91 days from the baseline)19.30 units on a scaleStandard Deviation 10.35
ShamChange From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit4(77~91 days from the baseline)17.13 units on a scaleStandard Deviation 12.95
ShamChange From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit1(Baseline)24.29 units on a scaleStandard Deviation 7.71
ShamChange From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit3(39~45 days from the baseline)18.42 units on a scaleStandard Deviation 10.91
ShamChange From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13Visit2(18~24 days from the baseline)19.43 units on a scaleStandard Deviation 8.79
p-value: 0.662Mixed Models Analysis
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit1(Baseline)3.19 units on a scaleStandard Deviation 1.01
Active (Real)Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit2(18~24 days from the baseline)2.87 units on a scaleStandard Deviation 0.94
Active (Real)Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit3(39~45 days from the baseline)2.74 units on a scaleStandard Deviation 1.04
Active (Real)Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit4(77~91 days from the baseline)2.75 units on a scaleStandard Deviation 1.11
ShamChange From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit4(77~91 days from the baseline)2.75 units on a scaleStandard Deviation 1.13
ShamChange From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit1(Baseline)3.35 units on a scaleStandard Deviation 0.89
ShamChange From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit3(39~45 days from the baseline)2.95 units on a scaleStandard Deviation 1.11
ShamChange From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13Visit2(18~24 days from the baseline)3.04 units on a scaleStandard Deviation 1.02
p-value: 0.639ANOVA
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit1(Baseline)42.39 units on a scaleStandard Deviation 11.45
Active (Real)Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit2(18~24 days from the baseline)46.58 units on a scaleStandard Deviation 11.39
Active (Real)Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit3(39~45 days from the baseline)48.83 units on a scaleStandard Deviation 11.67
Active (Real)Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit4(77~91 days from the baseline)49.51 units on a scaleStandard Deviation 12.1
ShamChange From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit4(77~91 days from the baseline)48.09 units on a scaleStandard Deviation 10.54
ShamChange From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit1(Baseline)42.09 units on a scaleStandard Deviation 11.12
ShamChange From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit3(39~45 days from the baseline)48.95 units on a scaleStandard Deviation 10.59
ShamChange From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13Visit2(18~24 days from the baseline)46.78 units on a scaleStandard Deviation 9.98
p-value: 0.452ANOVA
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit1(Baseline)36.83 units on a scaleStandard Deviation 17.74
Active (Real)Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit2(18~24 days from the baseline)34.39 units on a scaleStandard Deviation 17.86
Active (Real)Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit3(39~45 days from the baseline)30.73 units on a scaleStandard Deviation 18.42
Active (Real)Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit4(77~91 days from the baseline)27.19 units on a scaleStandard Deviation 18.95
ShamChange From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit4(77~91 days from the baseline)23.84 units on a scaleStandard Deviation 19.06
ShamChange From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit1(Baseline)36.40 units on a scaleStandard Deviation 16.37
ShamChange From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit3(39~45 days from the baseline)26.25 units on a scaleStandard Deviation 19.39
ShamChange From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13Visit2(18~24 days from the baseline)31.53 units on a scaleStandard Deviation 19.15
p-value: 0.318ANOVA
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
Active (Real)Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit1(Baseline)16.22 units on a scaleStandard Deviation 9.01
Active (Real)Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit2(18~24 days from the baseline)13.18 units on a scaleStandard Deviation 8.07
Active (Real)Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit3(39~45 days from the baseline)13.70 units on a scaleStandard Deviation 9.49
Active (Real)Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit4(77~91 days from the baseline)12.92 units on a scaleStandard Deviation 8.99
ShamChange From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit4(77~91 days from the baseline)13.15 units on a scaleStandard Deviation 10.48
ShamChange From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit1(Baseline)17.44 units on a scaleStandard Deviation 7.67
ShamChange From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit3(39~45 days from the baseline)13.11 units on a scaleStandard Deviation 8.7
ShamChange From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13Visit2(18~24 days from the baseline)14.62 units on a scaleStandard Deviation 9.09
p-value: 0.273ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026