Augmentative transcranial direct current stimulation (tDCS) in patients with bipolar depression: RCT, IIT study.

Seoul National University Bundang Hospital0 个研究点目标入组 64 人开始时间: 待定最近更新: 2020年1月14日

试验速览

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•(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

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