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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.

Conditions
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tDCS

Intervention / Treatment
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* Device: ACTIVE
* Device: SHAM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTIVE<br>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) | Device: ACTIVE<br>* 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.<br>|
| Sham Comparator: SHAM<br>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) | Device: SHAM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 2week, 4week, 6week | 
| Response rate of treatment | Response group: Reduce of HAM-D 50% | baseline, 6week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | baseline, 2week, 4week, 6week | 
| CGI-BP | Clinical Global Impression- Bipolar | baseline, 2week, 4week, 6week | 
| Q-LES-Q-SF | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form | baseline, 2week, 4week, 6week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorder, Depression, tDCS