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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Yband(YDT-201N); Device: Sham-Yband(YDT-201N)

• Registration Number: NCT02657980
• Lead Sponsor: Ybrain Inc.

Brief Summary

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

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-18
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YBand(YDT-201N)	Yband(YDT-201N)	transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)
Sham-Yband(YDT-201N)	Sham-Yband(YDT-201N)	sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	from baseline to Week 6	Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ybrain; 🇰🇷 Seoul, Korea, Republic of