The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.

Detailed Description
-----------------
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5 7 times a week and they were evaluated every 2weeks through questionnaires.

Official Title
-----------------
Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Mind STIM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features) Patients with a K-BDI-II score of 14 or more and 28 or less In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life. Exclusion Criteria: Patients diagnosed with Axis I disorders other than major depressive disorder Patients diagnosed with other depressive disorders besides major depressive disorder Patients who have attempted suicide within 6 months of screening Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems Patients judged to have other reasons for prohibition of use of tDCS medical devices Patients currently taking antidepressants

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YMS-201B<br>transcranial Direct Current Stimulation (tDCS) application 5  7 days a week for 6 weeks (total of 30 42 applications) | Device: Mind STIM<br>* transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-Beck Depression Inventory-II | Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms. | At 6 weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-Beck Anxiety Depression Inventory | 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. | Weeks 0, 2, 4, and 6 | 
| Hamilton Rating Scale for Depression | The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms. | Weeks 0, 2, 4, and 6 |