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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Depression Disorders; Depressive Disorder; Depression Disorder

Treatments: Combination Product: Five-Element Music 2 combined with antidepressant medication; Combination Product: Five-Element Music 1 combined with antidepressant medication; Other: No Intervention: Observational Cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT07048938

2024-100R

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

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

Experimental group

Treatment:

Combination Product: Five-Element Music 1 combined with antidepressant medication

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

Active Comparator group

Treatment:

Combination Product: Five-Element Music 2 combined with antidepressant medication

health control

Other group

Treatment:

Other: No Intervention: Observational Cohort