Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Hamilton Rating Scale for Depression (HAMD)
研究概览
简要总结
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
详细描述
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnostic criteria of DSM-IV for MDD
- •The range of the age from 18 to 70-year-old
- •Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
- •Competent for a full explanation of the study and written informed consent is obtained.
排除标准
- •Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
- •History or family history of seizure disorder
- •Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
- •Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAMD)
时间窗: From Weeks 0 to 24
The Hamilton Depression scale sum score (HAMD21) * Not depressed: 0-7 * Mild: 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: \>23
次要结局
- Response rate(From Weeks 0 to 24)
- Remission rate(From Weeks 0 to 24)
研究者
Kuan-Pin
China Medical University Hospital
National Science Council, Taiwan