NCT06484413已完成不适用
Repetitive Transcranial Magnetic Stimulation for Depression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- MADRS
研究概览
简要总结
This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 to 80 years of age
- •DSM V diagnosis of a major depressive episode Subjects must have an initial score of at least 20 on the HAMD at screen
- •rTMS is clinically indicated
- •Patient is competent to provide informed consent
排除标准
- •Lifetime DSM-V diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-V
- •Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression and is the primary diagnosis
- •Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
- •Diagnosis of mental retardation
- •Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
- •Any active general medical condition or CNS disease which can affect cognition or response to treatment
- •Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
- •ECT or rTMS within three months
- •Pregnancy as indicated by self-report
- •MRI contraindications
- •Implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc)
- •Change in the dose of psychotropic medications within the past week
- •Inclusion Criteria for healthy volunteers:
- •Male or female between age 18 and 80
- •Patient is competent to provide informed consent
- •Exclusion Criteria for healthy volunteers:
- •Lifetime history of major chronic mental illness, such as schizophrenia, major depression, or bipolar disorder
- •Lifetime history of psychiatric hospitalization because of any mental illness Mental illness, other than depression, that needed psychological or pharmacological treatment in the past
- •Any neurodevelopmental or neurodegenerative disease, or stroke or positive findings on past head CT or brain MRI
- •Hamilton Rating Scale for Depression (HRSD-17) is more than 7
- •MRI contraindications
结局指标
主要结局
MADRS
时间窗: 5 weeks
Montgomery-Asberg Depression Rating Scale
次要结局
未报告次要终点
研究者
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