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Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial direct current stimulation_High real
Transcranial direct current stimulation_Low real
Transcranial direct current stimulation_Sham
Sponsored by
ji hyun baek, MD, Ph.D
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:

  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:

  1. History of clinically significant medical neurological disease or history of head injury
  2. In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
  3. Severe suicidal risk or psychotic symptoms determined by the clinician
  4. In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
  5. 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
  6. 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
  7. Pregnant women
  8. Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

High real stimulation group

Low real stimulation group

Sham stimulation group

Arm Description

2mA tDCS stimulation daily (42 times) for 6 weeks

1mA tDCS stimulation daily (42 times) for 6 weeks

sham stimulation daily (42 times) for 6 weeks

Outcomes

Primary Outcome Measures

Working memory ability evaluation(N-Back tast)
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.

Secondary Outcome Measures

Hamilton Rating Scale
The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The lower the total score, the better the symptoms.
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.The lower the total score, the better the symptoms.

Full Information

First Posted
January 12, 2021
Last Updated
September 21, 2021
Sponsor
ji hyun baek, MD, Ph.D
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1. Study Identification

Unique Protocol Identification Number
NCT04709952
Brief Title
Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients
Official Title
A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ji hyun baek, MD, Ph.D

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 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, the investigator 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.
Detailed Description
During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High real stimulation group
Arm Type
Active Comparator
Arm Description
2mA tDCS stimulation daily (42 times) for 6 weeks
Arm Title
Low real stimulation group
Arm Type
Active Comparator
Arm Description
1mA tDCS stimulation daily (42 times) for 6 weeks
Arm Title
Sham stimulation group
Arm Type
Sham Comparator
Arm Description
sham stimulation daily (42 times) for 6 weeks
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation_High real
Intervention Description
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation_Low real
Intervention Description
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation_Sham
Intervention Description
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).
Primary Outcome Measure Information:
Title
Working memory ability evaluation(N-Back tast)
Description
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.
Time Frame
Change from Baseline Working memory ability evaluation at 6 weeks.
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale
Description
The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The lower the total score, the better the symptoms.
Time Frame
Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Title
Hamilton Anxiety Rating Scale
Description
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.The lower the total score, the better the symptoms.
Time Frame
Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks

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: Diagnosis of major depressive disorder CGI severity (severity of Illness) score of 3 or higher Patients receiving medication for depression at the time of study participation 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Baek
Phone
+82 2-2008-4388
Email
jh1.baek@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Baek
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woojae Myung, MD, PhD
Phone
+31)31-787-2720
Email
smbhealer@gmail.com
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Baek, M.D., Ph.D.
Phone
+82 1093355988
Email
jihyunbaek@skku.edu

12. IPD Sharing Statement

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Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients

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