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Effect of Self-administered tDCS in Patients With MDD

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS treatment
Antidepressant Drug(escitalopram)
Sponsored by
Jeong-Ho Chae
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

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 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
  • Has received Escitalopram as a combined antidepressant during the study period

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 Escitalopram 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 pimozide
  • Pregnant or has a positive pregnancy serum test.

Sites / Locations

  • Seoul St. Mary's Hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

sham tDCS treatment group

active tDCS treatment group

Arm Description

the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes

2mA of current was delivered during the 30 minutes of treatment

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)
Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms

Secondary Outcome Measures

Beck Depression Inventory (BDI)
The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms.
Montgomery-Asberg Depression Rating Scale
Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Beck Anxiety Inventory
Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. 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. The overall score ranges from 0 to 63.

Full Information

First Posted
August 28, 2020
Last Updated
September 8, 2020
Sponsor
Jeong-Ho Chae
Collaborators
Ybrain Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04543123
Brief Title
Effect of Self-administered tDCS in Patients With MDD
Official Title
Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeong-Ho Chae
Collaborators
Ybrain Inc.

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
In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Detailed Description
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham tDCS treatment group
Arm Type
Sham Comparator
Arm Description
the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes
Arm Title
active tDCS treatment group
Arm Type
Experimental
Arm Description
2mA of current was delivered during the 30 minutes of treatment
Intervention Type
Device
Intervention Name(s)
tDCS treatment
Intervention Description
Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).
Intervention Type
Drug
Intervention Name(s)
Antidepressant Drug(escitalopram)
Intervention Description
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Description
Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms
Time Frame
Change from Baseline Hamilton Depression Scale at 6 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms.
Time Frame
Weeks 0, 2, 4, and 6
Title
Montgomery-Asberg Depression Rating Scale
Description
Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Time Frame
Weeks 0, 2, 4, and 6
Title
Beck Anxiety Inventory
Description
Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. 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. The overall score ranges from 0 to 63.
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 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 Has received Escitalopram as a combined antidepressant during the study period 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 Escitalopram 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 pimozide Pregnant or has a positive pregnancy serum test.
Facility Information:
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Self-administered tDCS in Patients With MDD

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