NCT01909232已完成不适用
A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder
Cervel Neurotech, Inc.6 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2013年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 6
- 主要终点
- Change in depression severity
研究概览
简要总结
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.
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
- •Current major depressive disorder (MDD)
- •Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
- •On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
- •Weight less than 350 pounds
排除标准
- •Current major depressive disorder episode of more than three years
- •Seizure disorder
- •History of brain injury, stroke or active central nervous system disease
- •Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
- •Active suicidal intent or plan
- •Other significant psychiatric disorder
- •Alcohol or substance dependence or abuse
- •Prior treatment with transcranial magnetic stimulation
- •Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
- •If female, pregnant or lactating or planning to become pregnant within the next three months
研究组 & 干预措施
Active rTMS treatment
Experimental
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
干预措施: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator (Device)
Sham rTMS treatment
Sham Comparator
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
干预措施: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator (Device)
结局指标
主要结局
Change in depression severity
时间窗: Baseline to four weeks (the conclusion of rTMS treatment)
Measured by the 24-item Hamilton Rating Scale for Depression
次要结局
- Remission from depression(Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))
- Change in quality of life(Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))
- Incidence of treatment-emergent adverse events and serious adverse events(Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))
- Change in depression severity(Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))
- Clinically significant response(Baseline to eight weeks (four weeks after the conclusion of rTMS treatment))
- Clinically significant response(Baseline to four weeks (the conclusion of rTMS treatment))
- Remission from depression(Baseline to four weeks (the conclusion of rTMS treatment))
- Change in quality of life(Baseline to four weeks (the conclusion of rTMS treatment))
研究者
研究点 (6)
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