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

Ybrain Inc.96 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Yband(YDT-201N)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)DEVICE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ybrain

Seoul, South Korea

Outcomes

Primary Outcomes

Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Time frame: from baseline to Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.