NCT01370304Unknown3 期
Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Xijing Hospital1 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
- 1
- 主要终点
- The primary outcome measure is remission
研究概览
简要总结
The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Clinical diagnosis of major depressive disorder (DSM-IV)
- •HDRS-17 items > 20
- •Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)
排除标准
- •Psychotic features
- •Failure of one previous venlafaxine treatment
- •Addiction comorbidity or schizophrenia comorbidity
- •Involuntary hospitalization
- •Seizures history
- •Pregnancy or breastfeeding
- •Somatic comorbidity able to impact on cognitive functions
结局指标
主要结局
The primary outcome measure is remission
时间窗: 1-6 weeks
It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 \< 8)
次要结局
- QIDS-C30(1-6 weeks)
- fMRI(0,6 weeks)
- CGI(1-6 weeks)
- UKU Scale(1-6 weeks)
研究者
fengshufang
Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital
Xijing Hospital
研究点 (1)
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