A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronetics
- 入组人数
- 7,690
- 试验地点
- 1
- 主要终点
- Efficacy Outcome
研究概览
简要总结
To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.
详细描述
This is a retrospective analysis. The purpose of this study is to collate real world data (RWD) from existing medical records of patients aged 12 to 21 years who received treatment with NeuroStar Advanced Therapy for Major Depressive Disorder (MDD) as determined by scores on the PHQ-9 and CGI-S assessment tool into a central registry database.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-10 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins.
- •12 to 21 years of age.
- •Male or female.
- •Treatment with NeuroStar Advanced Therapy.
- •Treatment start-date of November 1, 2008, or later.
- •Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.
- •a) Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.
- •b) Intent-to-Treat (ITT) Subjects: Subject received at least one treatment with NeuroStar Advanced Therapy.
- •Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.
- •Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard per the current FDA clearance.
- •Each of GAD-7 and PHQ-9 scores available at each of pre-treatment (defined as the closest score available within 7 days prior to administration of the first treatment) and post-treatment (defined as the closest score available within ± 7 days of the date of the last treatment) evaluations for the single NeuroStar Advanced Therapy course.
- •Subjects with moderate or greater depression prior to NeuroStar Advanced Therapy (pre-treatment), defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10 within 7 days prior to the first treatment.
排除标准
- •Gap in NeuroStar Advanced Therapy treatment > 14 continuous days, where applicable.
- •More than one DLPFC treatment session on the same day.
结局指标
主要结局
Efficacy Outcome
时间窗: 8 weeks
To assess the pre-treatment to post-treatment change in PHQ-9 scores for the adolescent patient population. PHQ-9 is the Patient Health Questionnaire is a 9-question patient-completed assessment. Total scores range from 0 to 27. Higher the score means higher the depression severity.
次要结局
- Efficacy Outcome(8 weeks)