NCT04037592已完成不适用
Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients and Its Predictors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Percentage change in 17-item Hamilton Depression Rating Scale
研究概览
简要总结
This study evaluates an association between different dosage and the antidepressant efficacy of theta burst stimulation in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e. standardized dosage intermittent theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment or sham treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 是
入选标准
- •Male or female, 21 to 70 years of age.
- •Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
- •Participants failed to respond to at least one adequate antidepressant treatment in their current episode
- •Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
- •Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
- •Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.
排除标准
- •a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
- •Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
- •Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
- •Women with breastfeeding or pregnancy
- •Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)
结局指标
主要结局
Percentage change in 17-item Hamilton Depression Rating Scale
时间窗: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)
the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
次要结局
- the change of brain connectivity after 3-week iTBS treatment(Baseline, Week 3)
- Response rate after 3-week treatment at the end of iTBS sessions and three and six month after.(Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation))
- Changes in depression severity, rated by self-reported(Baseline, Week 1, Week 2, Week 3)
- Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation(Baseline, Week 3)
- Remission rate after 3-week treatment(Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation))
- Changes in Young Mania Rating Scale(Baseline, Week 1, Week 2, Week 3)
- Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation(Baseline, Week 3)
- Baseline brain connectivity and the further antidepressant efficacy of brain stimulation(Baseline, Week 3)
- Changes in EEG band before and after brain stimulation(Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment))
- Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation(Baseline, Week 3)
- Changes in Clinical Global Index(Baseline, Week 1, Week 2, Week 3)
- Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation(Baseline, Week 3)
- Changes in single-pulse stimulation before and after brain stimulation(Baseline, Week 3)
- Changes in paired-pulse stimulation before and after brain stimulation(Baseline, Week 3)
- Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale(Baseline, Week 1, Week 2, Week 3)
研究者
研究点 (2)
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