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Clinical effect and mechanism study of Five Elements Music Therapy(FEMT) on depression disorder

Clinical effect and mechanism study of Five Elements Music Therapy(FEMT) on depression disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001174
Enrollment
Unknown
Registered
2025-06-14
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Healthy control group:None
Experimental group:The self-made music piece "Five Elements Music 1" is combined with fluoxetine hydrochloride
Control group:The self-made music piece "Five Elements Music 2" is combined with fluoxetine hydrochloride

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with depressive disorders: (1) Meet the diagnostic criteria for depressive episodes of ICD-10; (2) Hamilton Depression Scale -17 items score =14 points; (3) Gender is not limited. Age: 18-60 years old (4) The diagnosis shall be confirmed by at least two physicians with the title of attending physician or above. (5) Have sufficient visual and auditory levels to ensure that the necessary checks and experiments for the research can be completed; (6) Sign the written informed consent form and agree to be enrolled in the trial as required by the research plan. Inclusion criteria for healthy controls: The age should be between 18 and 60 years old and the individual should be healthy without mental or physical illness.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients with depressive disorders: (1) 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; (2) There is a history of abuse of tobacco alcohol and other psychoactive substances; (3) Those with comorbidities of other mental disorders; (4) Had participated in other drug clinical trials before inclusion. Exclusion criteria for healthy controls: (1) 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; (2) There is a history of abuse of tobacco alcohol and other psychoactive substances; (3) Had participated in other drug clinical trials before inclusion.

Design outcomes

Primary

MeasureTime frame
The reduction rate of HAMD-17 after treatment;

Secondary

MeasureTime frame
EEG;Repetitive Set of Neuropsychological State Tests (RBANS Scale);The changes in syndrome types resulting from the combination of the four diagnostic methods;Indicators of the pulse diagnosis instrument;Hamilton Anxiety Scale (HAMA Scale);EM;Treatment Emergent Symptom Scale (TESS);

Countries

China

Contacts

Public ContactLanying Liu

Shanghai Mental Health Center

balindaliu@163.com13516816012

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026