Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJuly 3, 2025
June 1, 2025
6 months
June 12, 2025
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment
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
From enrollment to the end of the treatment at 4 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication
EXPERIMENTALFive-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medication
ACTIVE COMPARATORhealth control
OTHERInterventions
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
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
No intervention will be applied to healthy people
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
July 3, 2025
Study Start
July 1, 2025
Primary Completion
December 31, 2025
Study Completion
March 31, 2026
Last Updated
July 3, 2025
Record last verified: 2025-06