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

Ybrain

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Device: Yband(YDT-201N); Device: Sham-Yband(YDT-201N)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02657980

MUL003MDD

Details and patient eligibility

About

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

Full description

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.

Enrollment: 96 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups

YBand(YDT-201N)

Experimental group

Description:

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

Treatment:

Device: Yband(YDT-201N)

Sham-Yband(YDT-201N)

Sham Comparator group

Description:

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

Treatment:

Device: Sham-Yband(YDT-201N)