- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657980
The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
January 24, 2017 updated by: Ybrain Inc.
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
Study Overview
Status
Completed
Conditions
Intervention / 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
Interventional
Enrollment (Actual)
96
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Seoul, Korea, Republic of
- Ybrain
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YBand(YDT-201N)
transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)
|
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)
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transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: from baseline to Week 6
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Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
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from baseline to Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: At 6 weeks after treatment.
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The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.
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At 6 weeks after treatment.
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Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: At 6 weeks after treatment
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The percentage of subjects whose MADRS score is under 10 in week 6 after treatment.
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At 6 weeks after treatment
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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
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Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.
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At 2 weeks, 4 weeks and 6 weeks after treatment
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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
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Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.
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At 2 weeks, 4 weeks and 6 weeks after treatment
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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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At 2 weeks, 4 weeks and 6 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Seungwoo Lee, Ybrain Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 18, 2016
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUL003MDD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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