Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 5
- 主要终点
- Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
研究概览
简要总结
Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.
详细描述
As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.
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)
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
- •Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)
排除标准
- •Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials
研究组 & 干预措施
active transcranial direct current stimulation (tDCS)
daily active transcranial direct current stimulation (tDCS) use for 6 weeks
干预措施: transcranial direct current stimulation (tDCS) (Device)
sham transcranial direct current stimulation (tDCS)
daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks
干预措施: transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13
时间窗: From Visit1(baseline) to 91 days
It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0\~13: Minimal 14\~19: Mild depression 20\~28: Moderate depression 29\~63: Severe depression
Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13
时间窗: From Visit1(baseline) to 91 days
It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression
次要结局
- Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13(From Visit1(baseline) to 91 days)
- Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13(From Visit1(baseline) to 91 days)
- Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13(From Visit1(baseline) to 91 days)
- Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13(From Visit1(baseline) to 91 days)
研究者
Woo Jung Kim
Clinical Associate Professor
Yonsei University