tDCSNCT03974815
tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study
A study testing ACTIVE in people with tDCS, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- tDCS
- What is being tested?
- ACTIVE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Boondang Hospital
Seongnam-si, Boondang, Gyunggi, 13620
Woojae Myung, MD, PhD, +82)31-787-2720, smbhealer@gmail.com
About this study
Official title: Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.
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.
Read more
- 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.
Read the 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.
- Conditions
- tDCS
- Being tested
- ACTIVE, SHAM
- Keywords
- tDCS, Bipolar disorder, Depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVEDevice
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.
SHAMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Experimental | 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) Receives: Device: ACTIVE |
| SHAM | Sham comparator | 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) Receives: Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 2week, 4week, 6week
Response rate of treatment
Response group: Reduce of HAM-D 50%
Measured: baseline, 6week
Secondary outcomes (4)
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
Measured: baseline, 2week, 4week, 6week
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.
Measured: baseline, 2week, 4week, 6week
CGI-BP
Clinical Global Impression- Bipolar
Measured: baseline, 2week, 4week, 6week
Q-LES-Q-SF
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Measured: baseline, 2week, 4week, 6week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start25 Jun 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for tDCSStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Principal investigator, Woojae Myung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974815
- Sponsor's protocol ID
- YB_ST_IIT1901
- Status last verified
- Dec 2019
- First submitted
- 3 Jun 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36203828
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.
- ClinicalTrials.gov ID
- NCT03974815
- Acronym / sponsor ID
- YB_ST_IIT1901
- Conditions
- tDCS
- Keywords
- tDCS, Bipolar disorder, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | Experimental | Device: ACTIVEActive 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 | Sham comparator | Device: SHAMSham 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) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVEWe 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. | Device | ACTIVE |
| SHAMWe 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. | Device | SHAM |
Primary outcome
The changes in HAM-D
Time frame: baseline, 2week, 4week, 6week
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
Time frame: baseline, 6week
Response group: Reduce of HAM-D 50%
4 secondary outcomes
HAM-A
Time frame: baseline, 2week, 4week, 6week
YMRS
Time frame: baseline, 2week, 4week, 6week
CGI-BP
Time frame: baseline, 2week, 4week, 6week
Q-LES-Q-SF
Time frame: baseline, 2week, 4week, 6week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 36203828Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seoul National University Boondang Hospital
Seongnam-si, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE in people with tDCS, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in HAM-D (time frame: baseline, 2week, 4week, 6week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.