A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronetics
- 入组人数
- 6,456
- 主要终点
- Primary Objective
研究概览
简要总结
Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.
详细描述
The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •At least 18 years of age.
- •Treatment with NeuroStar TMS Therapy.
- •Treatment date of November 01, 2008 or later.
- •Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
- •Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
- •PHQ-9 scores available at baseline (pre-treatment).
- •Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.
排除标准
- 未提供
结局指标
主要结局
Primary Objective
时间窗: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
The primary objective of this study are to evaluate the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
次要结局
未报告次要终点