Clinical trial NCT03974815: 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
Overall status: UNKNOWN
Phase: NA
Conditions: tDCS
Keywords: tDCS
Bipolar disorder
Depression
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2019-06-05
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The changes in HAM-D
timeFrame: baseline, 2week, 4week, 6week
measure: Response rate of treatment
timeFrame: baseline, 6week
Secondary outcomes:
measure: HAM-A
timeFrame: baseline, 2week, 4week, 6week
measure: YMRS
timeFrame: baseline, 2week, 4week, 6week
measure: CGI-BP
timeFrame: baseline, 2week, 4week, 6week
measure: Q-LES-Q-SF
timeFrame: baseline, 2week, 4week, 6week
Other outcomes:
measure: qEEG
timeFrame: baseline, 2week
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Boondang Hospital
state: Boondang, Gyunggi
Study officials:
References:
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.