MINDSET: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of time spent in response
研究概览
简要总结
This proposal seeks to carry out a prospective, single-arm open label study aimed at sustaining treatment-resistant depression (TRD) response in patients with TRD who had responded to prior individualized resting-state functional connectivity (rs-FC)-guided intermittent theta burst stimulation (iTBS). It also seeks to detect and predict relapse risk by integrating rs-FC iTBS with a TMS-adapted needs-based symptom-titrated algorithm based longitudinal ECT (STABLE) maintenance scheduling algorithm, and passive digital biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/ female aged ≥ 21 to ≤ 70 years old
- •Able to give informed consent
- •Able to understand English
- •DSM-V diagnosis of current/ past major depressive disorder (MDD) episode
- •Non-response to an adequate trial (4 weeks) of at least 1 MDD medication as verified by a study clinician
- •Ability to comply with passive wearable use and weekly mobile assessments
- •Have previously completed a course of individualized, functional connectivity-guided accelerated iTBS and shown a clinical response (as defined by a ≥50% improvement in MADRS score against baseline, any time within 3 months following an acute iTBS course)
- •Able to comply with the full 12-month protocol inclusive of continuous digital monitoring
排除标准
- •DSM-5 psychotic disorder
- •Drug or alcohol abuse or dependence (preceding 3 months)
- •Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
- •Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
- •Tattoos containing ferromagnetic ink or permanent piercings
- •Pregnancy
- •Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)
- •Participant does not have the capacity to provide consent
研究组 & 干预措施
Individualized, resting-state functional connectivity-guided accelerated iTBS
干预措施: Individualized resting-state functional connectivity-guided iTBS (Device)
Individualized, resting-state functional connectivity-guided accelerated iTBS
干预措施: Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm (Diagnostic Test)
结局指标
主要结局
Percentage of time spent in response
时间窗: Baseline, and weekly for 12 months.
The investigators will compute the percentage of time spent in treatment-resistant depression (TRD) response over the course of each participant's time in the study. TRD response is defined by fulfilling the low relapse criteria in accordance with the (symptom-titrated algorithm-based longitudinal ECT) STABLE algorithm. In this study, low relapse potential would be a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≤9 or a MADRS score of 10-19 with \<3-point increase from baseline, and \<5-point increase in 4 consecutive weeks at any point in the study. MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60. Higher scores mean a worse outcome.
次要结局
- Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)(Baseline, and weekly for 12 months.)
- Beck Anxiety Index (BAI)(Baseline, and weekly for 12 months.)
- General Anxiety Disorder-7 (GAD-7)(Baseline, and weekly for 12 months.)
- EuroQol 5-Dimension (EQ-5D)(Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.)
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(Baseline, and weekly for 12 months.)
- Sheehan Disability Scale (SDS)(Baseline, and weekly for 12 months.)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, and weekly for 12 months.)