Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657980
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
Severance Hospital
Gangnam Severance Hospital
Myongji Hospital
CHA University
National Health Insurance Service Ilsan Hospital
Ajou University
Hallym University Medical Center
Information provided by (Responsible Party):
Ybrain Inc.

Tracking Information
First Submitted Date  ICMJE June 22, 2015
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: from baseline to Week 6 ]
Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02657980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: At 6 weeks after treatment. ]
    The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.
  • Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: At 6 weeks after treatment ]
    The percentage of subjects whose MADRS score is under 10 in week 6 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) [ Time Frame: 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.
  • Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II) [ Time Frame: 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 Korean-Beck Anxiety Depression Inventory (K-BAI) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
Official Title  ICMJE The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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)
  • Device: Sham-Yband(YDT-201N)
    transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Study Arms  ICMJE
  • Experimental: YBand(YDT-201N)
    transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)
    Intervention: Device: Yband(YDT-201N)
  • Sham Comparator: Sham-Yband(YDT-201N)
    sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)
    Intervention: Device: Sham-Yband(YDT-201N)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
96
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657980
Other Study ID Numbers  ICMJE MUL003MDD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ybrain Inc.
Study Sponsor  ICMJE Ybrain Inc.
Collaborators  ICMJE
  • Severance Hospital
  • Gangnam Severance Hospital
  • Myongji Hospital
  • CHA University
  • National Health Insurance Service Ilsan Hospital
  • Ajou University
  • Hallym University Medical Center
Investigators  ICMJE
Study Director: Seungwoo Lee Ybrain Company
PRS Account Ybrain Inc.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP