NCT01114477已完成不适用
NeuroStar TMS Therapy System: Data Management, Analysis and Reporting Format for Clinical Treatment Utilization and Outcomes (Protocol no. 19-50001-000,Rev D
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronetics
- 入组人数
- 307
- 试验地点
- 44
- 主要终点
- Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
研究概览
简要总结
The major objective of this observational study is to describe clinical outcomes of patients receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder
排除标准
- •Contraindications to treatment with TMS
结局指标
主要结局
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
时间窗: Baseline and 6 weeks
The primary outcome measure will reported as the change from baseline through 6 weeks for the total score on the PHQ-9.
次要结局
- Health Resource Utilization Questionnaire (HRU)(Baseline, 6 weeks, and 12 Months)
- Total score for the Clinical Global Impressions-Severity (CGI-S)(Baseline, 6 weeks and 12 Months)
- Total Score for the EuroQol Questionnaire (EQ-5D)(Baseline, 6 weeks, and 12 Months.)
- Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores(Baseline, 6 weeks, and 12 Months.)
- Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)(Baseline, 6 weeks and 12 Months)
研究者
研究点 (44)
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