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tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study

Primary Purpose

tDCS

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ACTIVE
SHAM
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for tDCS focused on measuring tDCS, Bipolar disorder, Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5
  • CGI Severity of lightness score ≥ 4 points
  • Taking mood stabilizers for at least four weeks before the day of screening

Exclusion Criteria:

  • A history of clinically significant internal neurological disorders or head injury
  • mental retardation or cognitive impairment that will affect to make a consent form.
  • Patients at risk of suicide that may require hospitalization as determined by clinicians
  • A person who is determined to be excluded for using tDCS medical device for other reason (e.g. metal plate is inserted on head, etc.)
  • A person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem

  • A woman who disagree with medically allowed contraception* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant

    * Medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, Intrauterine Device, etc.

  • pregnant woman or lactating woman
  • A person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons

Sites / Locations

  • Seoul National University Boondang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ACTIVE

SHAM

Arm Description

Active stimulation (tDCS) will be used in the dose of 2mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)

Sham stimulation (tDCS) will be used in the dose of 0mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)

Outcomes

Primary Outcome Measures

The changes in HAM-D
The changes in HAM-D(Hamilton Depression scale) will constitute the major research outcome measure. HAM-D17 clinician-administered scale assesses 17 items related to major depression (MD) Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4) ; 0=absent, 4=most severe. Total score: 0 to 66.
Response rate of treatment
Response group: Reduce of HAM-D 50%

Secondary Outcome Measures

HAM-A
Hamilton Anxiety Rating Scale Rating clinician-related Main purpose to assess the severity of symptoms of anxiety Population adults, adolescents and children The scale consists of 14 items Each item is scored on a scale of 0-4, with a total score range of 0-56 <17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe
YMRS
Young Mania Rating Scale Rating clinician-related or other trained rater Main purpose to assess the severity of symptoms of manic Population young adults and children The scale consists of 11 items Each item is scored on a scale of 0-8 or 0-4, with a total score range of 0-60 The higher score, the worse it means.
CGI-BP
Clinical Global Impression- Bipolar
Q-LES-Q-SF
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

Full Information

First Posted
June 3, 2019
Last Updated
December 23, 2019
Sponsor
Seoul National University Hospital
Collaborators
Ybrain Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03974815
Brief Title
tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study
Official Title
Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
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
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective and safe in the treatment Bipolar depression. Randomized, double-blind Controlled Clinical Trial. Subjects Adults (between 19 and 65 years of age) with Bipolar depression who meet the inclusion criteria and who agree to participate in the study Will recruit from clinical referrals. Active tDCS Anode - left DLPFC Cathode - right DLPFC Electric current is 2mA - Current is applied for 30 min Sham tDCS Same assembly is used Current is applied for 1 min Both groups 30~42 stimulation sessions on consecutive days. Baseline(visit 1), 2 week(visit 2), 4 week(visit 3), 6 week(visit 4), and 12 week(visit 5) Check compliance with mobile application(MINDD-CONNECT) connections.
Detailed Description
Assessment: Depression rating scale: HAM-D(Hamiltion Depresiion Rating Scale), HAM-A(Hamilton Anxiety Rating Scale) Maniac rating scale: YMRS(Young Mania rating scale) CGI-BP(Clinical Global Impression-Bipolar) Q-LES-Q-SF(Quality of Life Enjoyment and Satisfaction Short form) Q-LES-Q-Q(Quality of Life Enjoyment and Satisfaction Questionnaire) qEEG(Quantitative Electroencephalography) Check compliance with mobile application(MINDD-CONNECT) connections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
tDCS
Keywords
tDCS, Bipolar disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACTIVE
Arm Type
Experimental
Arm Description
Active stimulation (tDCS) will be used in the dose of 2mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)
Arm Title
SHAM
Arm Type
Sham Comparator
Arm Description
Sham stimulation (tDCS) will be used in the dose of 0mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)
Intervention Type
Device
Intervention Name(s)
ACTIVE
Intervention Description
We will use 28.26cm^2 round electrodes and a 2mA current for 30 minutes per day. This montage is known as "bifrontal" setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials.
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
We will use 28.26cm^2 round electrodes and a 0mA current for 30 minutes per day. This montage is known as "bifrontal" setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials.
Primary Outcome Measure Information:
Title
The changes in HAM-D
Description
The changes in HAM-D(Hamilton Depression scale) will constitute the major research outcome measure. HAM-D17 clinician-administered scale assesses 17 items related to major depression (MD) Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4) ; 0=absent, 4=most severe. Total score: 0 to 66.
Time Frame
baseline, 2week, 4week, 6week
Title
Response rate of treatment
Description
Response group: Reduce of HAM-D 50%
Time Frame
baseline, 6week
Secondary Outcome Measure Information:
Title
HAM-A
Description
Hamilton Anxiety Rating Scale Rating clinician-related Main purpose to assess the severity of symptoms of anxiety Population adults, adolescents and children The scale consists of 14 items Each item is scored on a scale of 0-4, with a total score range of 0-56 <17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe
Time Frame
baseline, 2week, 4week, 6week
Title
YMRS
Description
Young Mania Rating Scale Rating clinician-related or other trained rater Main purpose to assess the severity of symptoms of manic Population young adults and children The scale consists of 11 items Each item is scored on a scale of 0-8 or 0-4, with a total score range of 0-60 The higher score, the worse it means.
Time Frame
baseline, 2week, 4week, 6week
Title
CGI-BP
Description
Clinical Global Impression- Bipolar
Time Frame
baseline, 2week, 4week, 6week
Title
Q-LES-Q-SF
Description
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame
baseline, 2week, 4week, 6week
Other Pre-specified Outcome Measures:
Title
qEEG
Description
The changes of qEEG analysis
Time Frame
baseline, 2week

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: Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5 CGI Severity of lightness score ≥ 4 points Taking mood stabilizers for at least four weeks before the day of screening Exclusion Criteria: A history of clinically significant internal neurological disorders or head injury mental retardation or cognitive impairment that will affect to make a consent form. Patients at risk of suicide that may require hospitalization as determined by clinicians A person who is determined to be excluded for using tDCS medical device for other reason (e.g. metal plate is inserted on head, etc.) A person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem A woman who disagree with medically allowed contraception* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant * Medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, Intrauterine Device, etc. pregnant woman or lactating woman A person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons
Facility Information:
Facility Name
Seoul National University Boondang Hospital
City
Seongnam-si
State/Province
Boondang, Gyunggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woojae Myung, MD, PhD
Phone
+82)31-787-2720
Email
smbhealer@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36203828
Citation
Lee J, Lee CW, Jang Y, You JS, Park YS, Ji E, Yu H, Oh S, Ryoo HA, Cho N, Park JY, Yoon J, Baek JH, Park HY, Ha TH, Myung W. Efficacy and safety of daily home-based transcranial direct current stimulation as adjunct treatment for bipolar depressive episodes: Double-blind sham-controlled randomized clinical trial. Front Psychiatry. 2022 Sep 20;13:969199. doi: 10.3389/fpsyt.2022.969199. eCollection 2022.
Results Reference
derived

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tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study

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