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A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression.

Status Approved

First Submitted Date

2021/01/25
Registered Date

2021/02/03
Last Updated Date

2021/01/25

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005854
Unique Protocol ID	YB_ST_IIT2006
Public/Brief Title	Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients.
Scientific Title	A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT04709952
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-06-143-004
Approval Date	2020-12-28
Institutional Review Board Name	The IRB of Samsung Medical Center
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Ji-Hyun Baek
Title	MD, PhD
Telephone	+82-2-2008-4388
Affiliation	Samsung Medical Center
Address	81 Irwon-Ro Gangnam-gu. Seoul, Korea
Contact Person for Public Queries
Name	Ji-Hyun Baek
Title	MD, PhD
Telephone	+82-2-2008-4388
Affiliation	Samsung Medical Center
Address	81 Irwon-Ro Gangnam-gu. Seoul, Korea
Contact Person for Updating Information
Name	Ji-Hyun Baek
Title	MD, PhD
Telephone	+82-2-2008-4388
Affiliation	Samsung Medical Center
Address	81 Irwon-Ro Gangnam-gu. Seoul, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-29 Anticipated
Target Number of Participant	141
Primary Completion Date	2023-03-31 , Anticipated
Study Completion Date	2023-06-30 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-02-10 ,
Recruitment Status by Participating Study Site 2
Name of Study	Samsung Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-29 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Medical Device Development Fund
Organization Type	Others
Project ID	2014X44-01

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, we analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

Study Summary Information

Lay Summary

This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, we analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	The sham stimulation group, the low real stimulation group (1mA), and the high real stimulation group (2mA) were divided into three groups and treated every day (42 times in total) for 6 weeks.
Number of Arms	3
Arm 1	Arm Label High real stimulation group
	Target Number of Participant 47
	Arm Type Active comparator
	Arm Description Transcranial DCS (tDCS) is applied for 6weeks to patients with depressive disorder taking antidepressants in three groups: high real stimulation group (2mA)/day.
Arm 2	Arm Label Low real stimulation group
	Target Number of Participant 47
	Arm Type Active comparator
	Arm Description Transcranial DCS (tDCS) is applied for 6weeks to patients with depressive disorder taking antidepressants in three groups: high real stimulation group (1mA)/day.
Arm 3	Arm Label Sham stimulation group
	Target Number of Participant 47
	Arm Type Sham comparator
	Arm Description Transcranial DCS (tDCS) is applied for 6weeks to patients with depressive disorder taking antidepressants in three groups: Sham stimulation group (0mA)/day.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F32.9)Depressive episode, unspecified Depression
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description 1. Diagnosis of major depressive disorder 2. CGI severity (severity of Illness) score of 3 or higher 3. Patients receiving medication for depression at the time of study participation 4. Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires
Exclusion Criteria	History of clinically significant medical neurological disease or history of head injury In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research Severe suicidal risk or psychotic symptoms determined by the clinician In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head) Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial Pregnant women Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Working memory ability evaluation
Timepoint	Change from Baseline Working memory ability evaluation at 6 weeks]
Secondary Outcome(s) 1
Outcome	Hamilton Rating Scale
Timepoint	Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Secondary Outcome(s) 2
Outcome	Hamilton Anxiety Rating Scale
Timepoint	Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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