Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment
研究概览
简要总结
The goal of this clinical trial is to learn if Five-Elements Music Therapy works to treat depression disorder. It will also learn about the mechanism of action of Five-Elements Music Therapy of Traditional Chinese Medicine (TCM) for depression disorder. The main questions it aims to answer is: Can Five-Elements Music Therapy, primarily using Gong-mode and Zhi-mode tones, improve Hamilton Depression Rating Scale (HAMD) scale scores in patients with depression disorder by regulating prefrontal cortex function?
Researchers will compare customized five-element music 1 (featuring Gong-mode and Zhi-mode as the predominant tones) to customized five-element music 2 (featuring Shang-mode and Yu-mode as the predominant tones, with identical rhythm and pitch to music 1), while simultaneously observing electroencephalogram (EEG), eye movement, and pulse diagnostic data from a healthy control group, to see if customized five-element music 1 featuring Gong-mode and Zhi-mode as the predominant tones can significantly improve depressive states in patients with depressive disorder.
Participants will:
- Undergo Five-Element Music 1 or Five-Element Music 2 therapy twice daily for 4 weeks (28 days), with each session consisting of 30 minutes of music listening followed by 10 minutes of rest.
- Concurrently receive antidepressant therapy with fluoxetine hydrochloride.
- Undergo relevant examinations once every two weeks and record their levels of depression and anxiety (Hamilton Depression Rating Scale (HAMD) & Hamilton Anxiety Rating Scale (HAMA)).
- Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the diagnostic criteria for depressive episodes of ICD-10;
- •Hamilton Depression Scale -17 items score ≥14 points;
- •The diagnosis should be confirmed by at least two physicians with the title of attending physician or above.
- •Have sufficient visual and auditory levels to ensure that the necessary checks and experiments for the research can be completed;
- •Sign the written informed consent form and agree to be enrolled in the trial as required by the research plan.
排除标准
- •There are serious heart, liver and kidney diseases, organic brain diseases, serious cardiovascular diseases, tumors, blood history, rheumatism, malnutrition and neurodegenerative diseases, etc.
- •Depressive episodes secondary to other mental or physical illnesses;
- •There is a history of abuse of tobacco, alcohol and other psychoactive substances;
- •Those with comorbidities of other mental disorders;
- •Had participated in other drug clinical trials before inclusion.
研究组 & 干预措施
Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication
干预措施: Five-Element Music 1 combined with antidepressant medication (Combination Product)
Five-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medication
干预措施: Five-Element Music 2 combined with antidepressant medication (Combination Product)
health control
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment
时间窗: From enrollment to the end of the treatment at 4 weeks
Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment
次要结局
- Pulse diagnosis data(From enrollment to the end of treatment at 4 weeks)
- Hamilton Anxiety Rating Scale（HAMA）(From enrollment to the end of treatment at 4 weeks)
- Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）(From enrollment to the end of treatment at 4 weeks)
- Treatment Emergent Symptom Scale（TESS）(From enrollment to the end of treatment at 4 weeks)
- Event-related potential（ERP）(From enrollment to the end of treatment at 4 weeks)
- Eye Movement（EM）(From enrollment to the end of treatment at 4 weeks)