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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657980
• Other study ID #: MUL003MDD
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2015
• Last updated: January 24, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Ybrain Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Device:
• 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)
• Sham-Yband(YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Locations

Country	Name	City	State
Korea, Republic of	Ybrain	Seoul

Sponsors (8)

Lead Sponsor	Collaborator
Ybrain Inc.	Ajou University, CHA University, Gangnam Severance Hospital, Hallym University Medical Center, Myongji Hospital, National Health Insurance Service Ilsan Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)	from baseline to Week 6
Secondary	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.	At 6 weeks after treatment.
Secondary	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.	At 6 weeks after treatment
Secondary	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.	At 2 weeks, 4 weeks and 6 weeks after treatment
Secondary	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.	At 2 weeks, 4 weeks and 6 weeks after treatment
Secondary	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.	At 2 weeks, 4 weeks and 6 weeks after treatment