NCT04541563进行中（未招募）不适用
Neurostimulation & Depression Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ProofPilot
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in Beck Depression Inventory Score Baseline vs week 4
研究概览
简要总结
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a fully remote trial. Participants will be randomized in ProofPilot, and only the fulfillment center will know whether the participant is in the placebo or control arm.
Participants will be unblinded at week 4 at the crossover.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 21
- •US resident
- •Can receive packages to their home via UPS/Fedex/USPS
- •Major Depressive Disorder
- •PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)
- •PHQ-8 Score less than 20 (given remote study serious depressed should be excluded)
- •Read/write English
- •have not contemplated suicide in the past year
- •not been institutionalized for mental health issues.
- •not currently experiencing problems with alcohol or drug abuse
- •can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
- •can commit to two (2) 20 minute sessions per day for 8 weeks
- •has not used a brain stimulation treatment in one year
- •no suspected or known history of heart disease
- •no pacemaker
- •not under medical supervision for other serious medical condition
- •not taking opioids
- •is a resident of states in which we have licensed medical professionals
排除标准
- 未提供
结局指标
主要结局
Change in Beck Depression Inventory Score Baseline vs week 4
时间窗: Week 4
Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.
次要结局
- Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8(Week 8)
- Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8(Week 8)
- Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4(Week 4)
- Change in Hamilton Depression Score Baseline vs week 4(Week 4)
- Change in Hamilton Depression Score Baseline vs week 2(Week 2)
- Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2(Week 2)
研究者
研究点 (1)
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