The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Study Overview
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Brief Summary
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Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Detailed Description
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Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

Official Title
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The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Yband(YDT-201N)
* Device: Sham-Yband(YDT-201N)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features) Greater than 22 points of Montgomery-Asberg Depression Rating Scale Aged 19 to 65. Has provided informed consent Exclusion Criteria: Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.) History of suicidal attempt in the last 6 months Diagnosed with bipolar or psychotic major depressive disorder Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified. Has hypersensitivity to sertraline ingredients A score of 5 or greater for the question #10 in MADRS Diagnosed with closed angle glaucoma or has a history of glaucoma. History of participation in other clinical trials within 30days. A major and/or unstable medical or neurologic illness Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide Pregnant or has a positive pregnancy serum test.

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 |
| --- | --- |
| Experimental: YBand(YDT-201N)<br>transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications) | Device: Yband(YDT-201N)<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>|
| Sham Comparator: Sham-Yband(YDT-201N)<br>sham-tDCS application 5 days a week for 2 weeks (total of 10 applications) | Device: Sham-Yband(YDT-201N)<br>* transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | Measured by Montgomery-Åsberg Depression Rating Scale (MADRS) | from baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment. | At 6 weeks after treatment. | 
| Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | The percentage of subjects whose MADRS score is under 10 in week 6 after treatment. | At 6 weeks after treatment | 
| Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI) | Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment | 
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II) | Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment | 
| Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI) | Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively. | At 2 weeks, 4 weeks and 6 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation