Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder

Обзор

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: 1. 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. 2. Concurrently receive antidepressant therapy with fluoxetine hydrochloride. 3. 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)). 4. Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.

Вмешательства

• Комбинированный продукт Five-Element Music 1 combined with antidepressant medication
  The self-composed musical piece Five Elements Music 1 was selected to intervene with the patients, with the songs primarily based on the Gong tone and Zhi tone in traditional Chinese music. On this basis, the intervention was combined with fluoxetine hydrochloride treatment
• Комбинированный продукт Five-Element Music 2 combined with antidepressant medication
  The self-composed musical piece Five Elements Music 2 was selected to intervene with the patients, with the songs primarily based on the Shang mode (A) and Yu (E) mode in traditional Chinese music. On this basis, the intervention was combined with fluoxetine hydrochloride treatment
• Другое No Intervention: Observational Cohort
  No intervention will be applied to healthy people

Первичные конечные точки

• The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment [Срок оценки: From enrollment to the end of the treatment at 4 weeks]

Вторичные конечные точки (6)

• Hamilton Anxiety Rating Scale（HAMA） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Repeatable Battery for the Assessment of Neuropsychological Status（RBANS） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Treatment Emergent Symptom Scale（TESS） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Event-related potential（ERP） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Eye Movement（EM） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Pulse diagnosis data [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07048938 · 2024-100R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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