Effect of Self-administered tDCS in Patients With MDD

Study Overview
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Brief Summary
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In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.

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

Official Title
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Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: tDCS treatment
* Drug: Antidepressant Drug(escitalopram)


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 Has received Escitalopram as a combined antidepressant during the study period 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 Escitalopram 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 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham tDCS treatment group<br>the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes | Device: tDCS treatment<br>* Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).<br>Drug: Antidepressant Drug(escitalopram)<br>* Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.<br>|
| Experimental: active tDCS treatment group<br>2mA of current was delivered during the 30 minutes of treatment | Device: tDCS treatment<br>* Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).<br>Drug: Antidepressant Drug(escitalopram)<br>* Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms | Change from Baseline Hamilton Depression Scale at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) | The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms. | Weeks 0, 2, 4, and 6 | 
| Montgomery-Asberg Depression Rating Scale | Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | Weeks 0, 2, 4, and 6 | 
| Beck Anxiety Inventory | Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. 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. The overall score ranges from 0 to 63. | Weeks 0, 2, 4, and 6 |