Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ybrain Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTIVE | Experimental | 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) |
|
| SHAM | Sham Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTIVE | Device | 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. |
| 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
| baseline, 2week, 4week, 6week |
| Response rate of treatment | Response group: Reduce of HAM-D 50% | baseline, 6week |
| Measure | Description | Time Frame |
|---|---|---|
| HAM-A | Hamilton Anxiety Rating Scale
| baseline, 2week, 4week, 6week |
| Measure | Description | Time Frame |
|---|---|---|
| qEEG | The changes of qEEG analysis | baseline, 2week |
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Boondang Hospital | Recruiting | Seongnam-si | Boondang, Gyunggi | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36203828 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
Not provided
Not provided
Double blind
| SHAM | Device | 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. |
|
| YMRS | Young Mania Rating Scale
| 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 |
| D001519 |
| Behavior |