Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hamilton depression rating scale (HAM-D 17)
研究概览
简要总结
The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.
详细描述
The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
- •Antidepressant medication will be maintained throughout the study period.
排除标准
- •Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
- •To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.
结局指标
主要结局
Hamilton depression rating scale (HAM-D 17)
时间窗: baseline, 1, 2, and 4 weeks after TMS
measuring instrument of severity of depressive symptoms
次要结局
未报告次要终点
研究者
Doh Kwan Kim
M.D., Ph.D. / Professor
Samsung Medical Center