Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ybrain Inc.
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Korean-Beck Depression Inventory-II
研究概览
简要总结
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
详细描述
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 2weeks through questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
- •Patients with a K-BDI-II score of 14 or more and 28 or less
- •In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.
排除标准
- •Patients diagnosed with Axis I disorders other than major depressive disorder
- •Patients diagnosed with other depressive disorders besides major depressive disorder
- •Patients who have attempted suicide within 6 months of screening
- •Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
- •Patients judged to have other reasons for prohibition of use of tDCS medical devices
- •Patients currently taking antidepressants
结局指标
主要结局
Korean-Beck Depression Inventory-II
时间窗: At 6 weeks after treatment.
Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
次要结局
- Korean-Beck Anxiety Depression Inventory(Weeks 0, 2, 4, and 6)
- Hamilton Rating Scale for Depression(Weeks 0, 2, 4, and 6)