NCT00714090已完成3 期
Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
Club rTMS et Psychiatrie36 个研究点 分布在 2 个国家目标入组 170 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 36
- 主要终点
- The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.
详细描述
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •I or II bipolar disorder
- •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. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: 2 to 6 weeks
次要结局
- Onset of action for remission and response (HDRS-17 diminution > 50%)(2 to 6 weeks)
- Anxiety will be assessed using the Covi Anxiety Scale.(2 to 6 weeks)
- Side effects will be assessed using the UKU Scale.(2 to 6 weeks)
- Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)(2 to 6 weeks)
- Onset of action using the Clinical Global Impressions scale (CGI)(2 to 6 weeks)
研究者
Dr Emmanuel POULET
Medical Doctor
Club rTMS et Psychiatrie
研究点 (36)
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