tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depressio
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004603
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
(1)Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5
(2)CGI Severity of lightness score = 4 points
(3)Taking mood stabilizers for at least four weeks before the day of screening
(1) A history of clinically significant internal neurological disorders or head injury
(2) mental retardation or cognitive impairment that will affect to make a consent form.
(3) Patients at risk of suicide that may require hospitalization as determined by clinicians
(4) 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.)
(5) 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
(6) 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.
(7) pregnant woman or lactating woman
(8) A person who is not suitable for this clinical trial based on principal investigator’s determination other than above reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale
- Secondary Outcome Measures
Name Time Method HAM-A, YMRS, CGI-BP, Q-LES-Q-SF, qEEG