An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)
研究概览
简要总结
The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder
The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment
Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®
详细描述
This is a prospective, multi-center, open-label study.
Up to 1000 adult subjects, in a major depressive episode, who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode, are eligible to participate in this study if they are deemed to be appropriate candidates for TMS.
Overall study duration is expected to be approximately 4 years. The study duration per subject is anticipated to be approximately 1 year.
Hypothesis
The SAINT® Neuromodulation System will demonstrate effectiveness in the treatment of MDD as measured by CGI-I at the end of the treatment (cessation of stimulation).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- •Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.
- •No medical conditions that would preclude the safe use of TMS.
- •Primary psychiatrist has determined TMS to be an appropriate clinical option.
- •Able to provide consent and comply with all study requirements.
- •Negative pregnancy test at the intended time of SAINT™ 5-day acute course treatment and agreement to use effective birth control during SAINT® acute therapy.
排除标准
- •Have any contraindication to TMS (section 2 User Manual).
- •Have any contraindication to receiving an MRI
- •Participants with an abnormal brain MRI as determined by PI, study physician or designee.
- •Deemed by the PI, study physician or designee to be a high risk of suicide or has made a suicide attempt within the last 6 months.
- •Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.
结局指标
主要结局
Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)
时间窗: End of Stimulation Day 5
Clinical Global Impression-Improvement (CGI-I) score is based on a scale from zero (0) - Not Assessed to seven (7) Very Much Worse with lower scores showing improvement and higher scores showing little or no improvement.
次要结局
- To test the durability of the antidepressant effect by assessing the Clinical Global Impression Severity Scale (CGI-S) after cessation of stimulation(3, 6, 9, 12 month follow up visit)
- Cambridge Brain Science Tools assessment score change in comparison with change in MADRS scores from baseline to cessation of stimulation(Baseline to End of Stimulation Day 5)
- Montgomery-Asberg Depression Rating Scale (MADRS) score change from baseline to cessation of stimulation in comparison with bioimaging assessments MADRS score change from baseline to cessation of stimulation in comparison with bioimaging assessments(Baseline to End Stimulation Day 5)