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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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YBand(YDT-201N)

transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)

Group Type EXPERIMENTAL

Yband(YDT-201N)

Intervention Type DEVICE

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)

Sham-Yband(YDT-201N)

sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)

Group Type SHAM_COMPARATOR

Sham-Yband(YDT-201N)

Intervention Type DEVICE

transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Interventions

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Yband(YDT-201N)

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)

Intervention Type DEVICE

Sham-Yband(YDT-201N)

transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Intervention Type DEVICE

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No