tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study
NCT ID: NCT03974815
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
64 participants
INTERVENTIONAL
2019-06-25
2020-10-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACTIVE
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)
ACTIVE
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.
SHAM
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)
SHAM
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.
Interventions
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ACTIVE
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.
SHAM
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.
Eligibility Criteria
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Inclusion Criteria
* CGI Severity of lightness score ≥ 4 points
* Taking mood stabilizers for at least four weeks before the day of screening
Exclusion Criteria
* 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
19 Years
65 Years
ALL
No
Sponsors
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Ybrain Inc.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Woojae Myung
Principal Investigator
Locations
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Seoul National University Boondang Hospital
Seongnam-si, Boondang, Gyunggi, South Korea
Countries
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Facility Contacts
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Woojae Myung, MD, PhD
Role: primary
References
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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.
Other Identifiers
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YB_ST_IIT1901
Identifier Type: -
Identifier Source: org_study_id