The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
研究概览
简要总结
In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
详细描述
In this project, the investigator evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. Patients were included in two groups and received an accelerated stimulation or sham treatment. The changes of neuroimaging and biomarkers at baseline, 5 days after treatment and 1 month after treatment are evaluated. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
- •24-item Hamilton Depression Scale (HAMD-24) ≥
- •Age 18-45 years, regardless of gender.
- •Right-handedness.
- •Han Chinese.
- •Signed a written informed consent, willing to participate in the study and be evaluated.
排除标准
- •Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
- •Patients with metal objects in the body or with other contraindications to MRI scanning
- •Patients with severe or unstable somatic diseases
- •Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
- •Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
研究组 & 干预措施
active iTBS
The active group of TRD will receive the accelerated intermittent TBS(iTBS).The iTBS cycles including 10 bursts of three pulses at 50 Hz were delivered in 2-second trains. Each iTBS session comprised 60 x 2 second trains, with an 8-second intertrain interval and total duration of 10-minutes.Treatment sessions were administered hourly 10 times a day totaling 18,000 pulses/day. Patients received this treatment protocol for 5 consecutive days (90,000 pulses in total).
干预措施: active iTBS (Device)
sham rTMS
The sham group of TRD will receive sham rTMS stimulation.
干预措施: sham rTMS (Device)
结局指标
主要结局
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
时间窗: Baseline, 5-day, 1-month
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8.
次要结局
- Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.(Baseline, 5-day, 1-month)
- Change in the rate of Beck Scale of Suicidal Ideation score after treatment.(Baseline, 5-day, 1-month)
- Change in the rate of Hamilton Anxiety Scale score after treatment.(Baseline, 5-day, 1-month)