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

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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.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Yband(YDT-201N) Device: Sham-Yband(YDT-201N) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: YBand(YDT-201N)
transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)
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 Comparator: Sham-Yband(YDT-201N)
sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)
Device: Sham-Yband(YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657980


Locations
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Korea, Republic of
Ybrain
Seoul, Korea, Republic of
Sponsors and Collaborators
Ybrain Inc.
Severance Hospital
Gangnam Severance Hospital
Myongji Hospital
CHA University
National Health Insurance Service Ilsan Hospital
Ajou University
Hallym University Medical Center
Investigators
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Study Director: Seungwoo Lee Ybrain Company

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Responsible Party: Ybrain Inc.
ClinicalTrials.gov Identifier: NCT02657980     History of Changes
Other Study ID Numbers: MUL003MDD
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Ybrain Inc.:
Major Depressive Disorder
tDCS
MDD
transcranial Direct Current Stimulation

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms