Imaging Biomarkers for TMS Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Depressive Symptoms at 4 Weeks
研究概览
简要总结
The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of major depressive disorder
- •Male and female subjects, ages 22-65
- •Have failed at least 1 antidepressant medication at adequate dose and duration
- •On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy
排除标准
- •Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
- •Active substance abuse, including alcohol
- •Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
- •No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
- •Pregnant or trying to get pregnant
- •Failed to respond to an adequate course of electroconvulsive therapy (ECT)
- •Previous treatment with TMS
- •Current depressive episode longer than 5 years
结局指标
主要结局
Depressive Symptoms at 4 Weeks
时间窗: 4 weeks after baseline
MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
次要结局
- Depression Symptoms at 4 Weeks- Secondary(4 weeks after baseline)
研究者
Stephan Taylor
Professor of Psychiatry
University of Michigan