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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
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.
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.
Seoul National University Boondang Hospital
Seongnam-si, Boondang, Gyunggi, South Korea
RECRUITINGThe 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.
Time frame: baseline, 2week, 4week, 6week
Response rate of treatment
Response group: Reduce of HAM-D 50%
Time frame: baseline, 6week
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
Time frame: 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.
Time frame: baseline, 2week, 4week, 6week
CGI-BP
Clinical Global Impression- Bipolar
Time frame: baseline, 2week, 4week, 6week
Q-LES-Q-SF
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: baseline, 2week, 4week, 6week
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