Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 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 brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, 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
- 否
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.
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)
研究组 & 干预措施
Active rTMS-DLPFC
This active group will receive high-frequency repetitive TMS stimulation.
干预措施: Active rTMS-DLPFC (Device)
Active iTBS-DLPFC
This active group will receive intermittent theta-burst TMS stimulation.
干预措施: Active iTBS-DLPFC (Device)
Sham TBS-DLPFC or Sham rTMS-DLPFC
Patients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil.
干预措施: Sham TBS-DLPFC or Sham rTMS-DLPFC (Device)
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 4(day 20)
the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
次要结局
- Response rate after 4-week treatment at the end of TMS sessions and three month after.(Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80))
- Changes in Clinical Global Index(Baseline, Week 1, Week 2, Week 3, Week 4(day 20))
- The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation(Baseline, Week 4(day 20))
- Changes in EEG band before and after brain stimulation(Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment))
- Changes in depression severity, rated by self-reported(Baseline, Week 1, Week 2, Week 3, Week 4(day 20))
- Changes in Young Mania Rating Scale(Baseline, Week 1, Week 2, Week 3, Week 4(day 20))
- The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation(Baseline, Week 4(day 20))
- The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation(Baseline, Week 4(day 20))
- The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation(Baseline, Week 4(day 20))
- Remission rate after 4-week treatment(Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80))