Comparison of the Efficacy of Different Modes of Accelerated Transcranial Magnetic Stimulation in Treatment-resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Hamilton Depression Scale (24-items) Total Score Change
研究概览
简要总结
To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients.
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
- Single (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
- 否
入选标准
- •The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects
- •After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method
- •3.24-item Hamilton depression Scale score ≥20
- •4.The age ranged from 18 to 45 years, both sexes
- •5.Right handed
- •6.Written informed consent was obtained and patients volunteered to participate in the study and be evaluated.
排除标准
- •Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc.
- •Suffering from serious or unstable physical diseases
- •3, pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive
- •Subjects with metal objects in the body or other contraindications to MRI scanning
- •There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.
研究组 & 干预措施
HL intervention group
The motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days.
干预措施: Noninvasive transcranial magnetic stimulation was administered 10 times daily (Procedure)
TT intervention group
The motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days.
干预措施: Noninvasive transcranial magnetic stimulation was administered six times daily (Procedure)
sham group
The appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group.
干预措施: Sham (Procedure)
结局指标
主要结局
Hamilton Depression Scale (24-items) Total Score Change
时间窗: Baseline to end of stimulation period, an average of 5 days
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. 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. A reduction of 50% or more in total score from Baseline indicates clinical response.
次要结局
- Change in the rate of Hamilton Anxiety Scale score(Time Frame: Baseline to end of stimulation period, an average of 5 days)