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

NCT ID: NCT07048938

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication

Group Type: EXPERIMENTAL

Five-Element Music 1 combined with antidepressant medication

Intervention Type: COMBINATION_PRODUCT

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

Five-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medication

Group Type: ACTIVE_COMPARATOR

Five-Element Music 2 combined with antidepressant medication

Intervention Type: COMBINATION_PRODUCT

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

health control

Group Type: OTHER

No Intervention: Observational Cohort

Intervention Type: OTHER

No intervention will be applied to healthy people

Interventions

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

Intervention Type: 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

Intervention Type: COMBINATION_PRODUCT

No Intervention: Observational Cohort

No intervention will be applied to healthy people

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent Form for Participants (Intervention Group)

View Document

Document Type: Informed Consent Form: Informed Consent Form for Participants (Healthy Group)

View Document

Other Identifiers

2024-100R

Identifier Type: -

Identifier Source: org_study_id