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Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
Yonsei University
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:

  • Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Exclusion Criteria:

  • Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

Sites / Locations

  • Hallym Univsity Chuncheon Sacred Heart HospitalRecruiting
  • National Health Insurance Service IlsanhospitalRecruiting
  • Myongji HospitalRecruiting
  • Catholic Kwandong University International St. Mary'S HospitalRecruiting
  • Yongin Severance Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active transcranial direct current stimulation (tDCS)

sham transcranial direct current stimulation (tDCS)

Arm Description

daily active transcranial direct current stimulation (tDCS) use for 6 weeks

daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks

Outcomes

Primary Outcome Measures

Change from baseline in depressive symptoms on Beck Depression Inventory-II (BDI-II) at week 13
It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0~13: Minimal 14~19: Mild depression 20~28: Moderate depression 29~63: Severe depression
Change from baseline in depressive symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at week 13
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression

Secondary Outcome Measures

Change from baseline in depressive symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at week 13
Epidemiologic Studies Depression Scale Revised test was revised to reflect the major depressive illustration diagnostic criteria for the evaluation of depression. Items reflecting anaesthesia, mental exercise delay/anxiety, and suicide accidents have been added, and are measured as 0 to 4 points per question on a self-report 20 question scale. The score ranges from 0~80 points. . A score equal to or above 16 indicates a person at risk for clinical depression.
Change from baseline in depressive symptoms on Hamilton Anxiety Scale (HAM-A) at week 13
The scale developed by Hamilton consists of 14 questions, and is evaluated by the clinician on a 5-point Likert scale of a semi-structured interview tool. The score ranges from 0~56 points. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Change from baseline in depressive symptoms on Clinical Global Impression-Severity of Illness scale (CGI-SI) at week 13
It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. The score ranges from 0~7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill
Change from baseline in depressive symptoms on Digit Symbol Substitution Test (DSST) at week 13
t is possible to measure high-dimensional cognitive functions such as perceptual organization ability and visual movement coordination, and examine attentional concentration, visual short-term memory, and mental movement speed. A post-marketing survey (PMS) on a new mechanism of anti-depressant (vortioxetine) is used to measure cognitive function before and after the use of the antidepressant in depressed patients. The score is the number of correct number-symbol matches achieved in 90 s. The score ranges from 0~93 points.

Full Information

First Posted
September 8, 2022
Last Updated
January 24, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05539131
Brief Title
Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients
Official Title
Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

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

5. Study Description

Brief Summary
Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.
Detailed Description
As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active transcranial direct current stimulation (tDCS)
Arm Type
Active Comparator
Arm Description
daily active transcranial direct current stimulation (tDCS) use for 6 weeks
Arm Title
sham transcranial direct current stimulation (tDCS)
Arm Type
Sham Comparator
Arm Description
daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms on Beck Depression Inventory-II (BDI-II) at week 13
Description
It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0~13: Minimal 14~19: Mild depression 20~28: Moderate depression 29~63: Severe depression
Time Frame
Screening Visit, Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)
Title
Change from baseline in depressive symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at week 13
Description
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression
Time Frame
Screening Visit, Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)
Secondary Outcome Measure Information:
Title
Change from baseline in depressive symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at week 13
Description
Epidemiologic Studies Depression Scale Revised test was revised to reflect the major depressive illustration diagnostic criteria for the evaluation of depression. Items reflecting anaesthesia, mental exercise delay/anxiety, and suicide accidents have been added, and are measured as 0 to 4 points per question on a self-report 20 question scale. The score ranges from 0~80 points. . A score equal to or above 16 indicates a person at risk for clinical depression.
Time Frame
Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)
Title
Change from baseline in depressive symptoms on Hamilton Anxiety Scale (HAM-A) at week 13
Description
The scale developed by Hamilton consists of 14 questions, and is evaluated by the clinician on a 5-point Likert scale of a semi-structured interview tool. The score ranges from 0~56 points. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)
Title
Change from baseline in depressive symptoms on Clinical Global Impression-Severity of Illness scale (CGI-SI) at week 13
Description
It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. The score ranges from 0~7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill
Time Frame
Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)
Title
Change from baseline in depressive symptoms on Digit Symbol Substitution Test (DSST) at week 13
Description
t is possible to measure high-dimensional cognitive functions such as perceptual organization ability and visual movement coordination, and examine attentional concentration, visual short-term memory, and mental movement speed. A post-marketing survey (PMS) on a new mechanism of anti-depressant (vortioxetine) is used to measure cognitive function before and after the use of the antidepressant in depressed patients. The score is the number of correct number-symbol matches achieved in 90 s. The score ranges from 0~93 points.
Time Frame
Baseline, 18~24 days from the baseline (Visit 2), 39~45 days from the baseline (Visit 3), 77~91 days from the baseline (Follow-up 1)

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: Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD) Exclusion Criteria: Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Areum Kim
Phone
82-10-7494-5591
Email
kima@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Jung Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym Univsity Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon
ZIP/Postal Code
24253
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daeyoung Noh
Phone
82-10-2721-0675
Email
omydoc@naver.com
Facility Name
National Health Insurance Service Ilsanhospital
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10444
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeseob Park
Phone
82-10-8512-5110
Email
seob0115@gmail.com
Facility Name
Myongji Hospital
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10475
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingu Jang
Phone
82-10-3237-5545
Email
realishia@hanmail.net
Facility Name
Catholic Kwandong University International St. Mary'S Hospital
City
Incheon
State/Province
Gyeonggi
ZIP/Postal Code
22711
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyungun Jung
Phone
82-10-9056-3807
Email
kyungun12@gmail.com
Facility Name
Yongin Severance Hospital, Yonsei University College of Medicine
City
Yongin
State/Province
Gyeonggi
ZIP/Postal Code
16995
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Jung Kim
Phone
82-10-9282-7943
Email
woojungkim@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Personal information collected for research purposes shall be kept anonymously in a safe place within the institute to be managed so that personal information is not exposed.
IPD Sharing Time Frame
After the completion of the study, the data will be available for 3 years.
IPD Sharing Access Criteria
For data security, encrypted communication methods will be used and restricted access to only authorized licensed personnel on the e-CRF domain.
IPD Sharing URL
https://console.redea.io/
Citations:
PubMed Identifier
35078951
Citation
Oh J, Jang KI, Jeon S, Chae JH. Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2022 Feb 28;20(1):87-96. doi: 10.9758/cpn.2022.20.1.87.
Results Reference
result
PubMed Identifier
25983531
Citation
Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.
Results Reference
result
PubMed Identifier
34915885
Citation
Wang J, Luo H, Schulke R, Geng X, Sahakian BJ, Wang S. Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. BMC Med. 2021 Dec 17;19(1):319. doi: 10.1186/s12916-021-02181-4.
Results Reference
result

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Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

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