NCT01370291Unknown3 期
Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study
Xijing Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PANSS
研究概览
简要总结
The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 16-45 years
- •Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
- •PANSS>=60
- •First episode, and the patients haven't use any antipsychotic drugs
排除标准
- •Suicide risk
- •Diagnose of substance abuse/dependance
- •Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
- •Contraindication to TMS:
- •Implanted pacemaker
- •Medication pump
- •Vagal stimulator
- •Deep brain stimulator
- •Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- •Signs of increased intracranial pressure
- •Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- •Estimated IQ less than 80
- •Have a sibling or parent with epilepsy
结局指标
主要结局
PANSS
时间窗: 1-6 weeks
次要结局
- Total AHRS score(1-6 weeks)
- HAMD Score(1-6 weeks)
- CGI(1-6 weeks)
- fMRI(0,6 week)
研究者
fengshufang
Fourth Military Medical University, Department of Psychiatry, Xi Jing hospital
Xijing Hospital
研究点 (2)
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