Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Response rate of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Response rate of treatment
时间窗: baseline, 6week
Response group: Reduce of HAM-D 50%
The changes in HAM-D
时间窗: baseline, 2week, 4week, 6week
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.
次要结局
- CGI-BP(baseline, 2week, 4week, 6week)
- HAM-A(baseline, 2week, 4week, 6week)
- YMRS(baseline, 2week, 4week, 6week)
- Q-LES-Q-SF(baseline, 2week, 4week, 6week)
研究者
Woojae Myung
Principal Investigator
Seoul National University Hospital