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

Summary

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.

Conditions

• Depression Disorder
• Depression Disorders
• Depressive Disorder

Interventions

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

OTHER

No Intervention: Observational Cohort

No intervention will be applied to healthy people

Sponsors & Collaborators

• Shanghai Mental Health Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-12-31

Completion

2026-03-31