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The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mind STIM
Sponsored by
Ybrain Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
  • Patients with a K-BDI-II score of 14 or more and 28 or less
  • In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.

Exclusion Criteria:

  • Patients diagnosed with Axis I disorders other than major depressive disorder
  • Patients diagnosed with other depressive disorders besides major depressive disorder
  • Patients who have attempted suicide within 6 months of screening
  • Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
  • Patients judged to have other reasons for prohibition of use of tDCS medical devices
  • Patients currently taking antidepressants

Sites / Locations

  • YBrain Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YMS-201B

Arm Description

transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 6 weeks (total of 30~42 applications)

Outcomes

Primary Outcome Measures

Korean-Beck Depression Inventory-II
Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.

Secondary Outcome Measures

Korean-Beck Anxiety Depression Inventory
The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Hamilton Rating Scale for Depression
The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms.

Full Information

First Posted
January 18, 2021
Last Updated
January 18, 2021
Sponsor
Ybrain Inc.
Collaborators
The Catholic University of Korea, Inje University, Korea University, Seoul National University Bundang Hospital, Hallym University Medical Center, Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04720040
Brief Title
The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
Official Title
Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ybrain Inc.
Collaborators
The Catholic University of Korea, Inje University, Korea University, Seoul National University Bundang Hospital, Hallym University Medical Center, Soonchunhyang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
Detailed Description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 2weeks through questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YMS-201B
Arm Type
Experimental
Arm Description
transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 6 weeks (total of 30~42 applications)
Intervention Type
Device
Intervention Name(s)
Mind STIM
Intervention Description
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)
Primary Outcome Measure Information:
Title
Korean-Beck Depression Inventory-II
Description
Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
Time Frame
At 6 weeks after treatment.
Secondary Outcome Measure Information:
Title
Korean-Beck Anxiety Depression Inventory
Description
The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Time Frame
Weeks 0, 2, 4, and 6
Title
Hamilton Rating Scale for Depression
Description
The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms.
Time Frame
Weeks 0, 2, 4, and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features) Patients with a K-BDI-II score of 14 or more and 28 or less In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life. Exclusion Criteria: Patients diagnosed with Axis I disorders other than major depressive disorder Patients diagnosed with other depressive disorders besides major depressive disorder Patients who have attempted suicide within 6 months of screening Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems Patients judged to have other reasons for prohibition of use of tDCS medical devices Patients currently taking antidepressants
Facility Information:
Facility Name
YBrain Inc.
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13449
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

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