NCT02657980已完成3 期
The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ybrain Inc.
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
详细描述
Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.
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
- •Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
- •Greater than 22 points of Montgomery-Asberg Depression Rating Scale
- •Aged 19 to
- •Has provided informed consent
排除标准
- •Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
- •History of suicidal attempt in the last 6 months
- •Diagnosed with bipolar or psychotic major depressive disorder
- •Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
- •Has hypersensitivity to sertraline ingredients
- •A score of 5 or greater for the question #10 in MADRS
- •Diagnosed with closed angle glaucoma or has a history of glaucoma.
- •History of participation in other clinical trials within 30days.
- •A major and/or unstable medical or neurologic illness
- •Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide
- •Pregnant or has a positive pregnancy serum test.
结局指标
主要结局
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: from baseline to Week 6
Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
次要结局
- Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)(At 6 weeks after treatment)
- Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)(At 6 weeks after treatment.)
- Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)(At 2 weeks, 4 weeks and 6 weeks after treatment)
- Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)(At 2 weeks, 4 weeks and 6 weeks after treatment)
- Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)(At 2 weeks, 4 weeks and 6 weeks after treatment)
研究者
研究点 (2)
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