tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study
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|ClinicalTrials.gov Identifier: NCT03974815|
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : December 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|tDCS||Device: ACTIVE Device: SHAM||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind|
|Official Title:||Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
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)
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 Comparator: 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)
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.
- 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.
- 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%
- HAM-A [ Time Frame: baseline, 2week, 4week, 6week ]
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
- YMRS [ Time Frame: baseline, 2week, 4week, 6week ]
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.
- CGI-BP [ Time Frame: baseline, 2week, 4week, 6week ]Clinical Global Impression- Bipolar
- Q-LES-Q-SF [ Time Frame: baseline, 2week, 4week, 6week ]Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
- qEEG [ Time Frame: baseline, 2week ]The changes of qEEG analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974815
|Korea, Republic of|
|Seoul National University Boondang Hospital||Recruiting|
|Seongnam-si, Boondang, Gyunggi, Korea, Republic of, 13620|
|Contact: Woojae Myung, MD, PhD +82)31-787-2720 firstname.lastname@example.org|