Depression DisorderNCT07048938
Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
A study testing Five-Element Music 1 combined with antidepressant medication and Five-Element Music 2 combined with antidepressant medication in people with Depression Disorder and Depression Disorders, run by Shanghai Mental Health Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder, Depression Disorders, Depressive Disorder
- What is being tested?
- Five-Element Music 1 combined with antidepressant medication and Five-Element Music 2 combined with antidepressant medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read more
Participants will:
- 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.
- Concurrently receive antidepressant therapy with fluoxetine hydrochloride.
- 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)).
- Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.
- Being tested
- Five-Element Music 1 combined with antidepressant medication, Five-Element Music 2 combined with antidepressant medication, No Intervention: Observational Cohort
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five-Element Music 1 combined with antidepressant medicationCombination 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 combined with antidepressant medicationCombination 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
No Intervention: Observational CohortOther
No intervention will be applied to healthy people
| Study group | Role | What they receive |
|---|---|---|
| Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication | Experimental | Not described Receives: 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 | Not described Receives: Combination Product: Five-Element Music 2 combined with antidepressant medication |
| health control | Other | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of the treatment at 4 weeks
Secondary outcomes (6)
Hamilton Anxiety Rating Scale（HAMA）
HAMA scale is used to assess the severity of anxiety symptoms in patients with neurotic disorders and other conditions. Previous studies have reported good reliability and validity for this scale. According to the evaluation criteria provided by the Chinese Psychiatric Rating Scale Cooperative Group:
- A total score above 29 indicates severe anxiety;
- Above 21 indicates definite marked anxiety;
- Above 14 indicates definite anxiety;
- Above 7 suggests possible anxiety;
- Below 7 signifies no anxiety symptoms. Previous studies have commonly used 14 as the cut-off score, with higher total scores indicating more severe anxiety symptoms.
Measured: From enrollment to the end of treatment at 4 weeks
Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）
This scale is used to assess participants' cognitive function. It offers advantages in clinical applications including concise administration, user-friendly operation, and sensitive/responsive results. Patients experiencing depressive episodes demonstrate high compliance with completion. The RBANS includes five domain scores:
- Immediate Memory: Reflects the participant's ability to retain information immediately after presentation;
- Visuospatial/Constructional: Reflects the participant's ability to perceive spatial relationships and accurately reproduce drawings;
- Language: Reflects the participant's verbal fluency and naming abilities; ④ Attention: Reflects the participant's working memory capacity and ability to access short-term memory stores through visual and verbal modalities; ⑤ Delayed Memory: Reflects the participant's anterograde memory capacity.
Measured: From enrollment to the end of treatment at 4 weeks
Treatment Emergent Symptom Scale（TESS）
Among comparable scales, it provides the most comprehensive item coverage-assessing both common adverse symptoms/signs and multiple laboratory findings. The Treatment Emergent Symptom Scale (TESS) requires clinicians to evaluate each symptom across three dimensions: Severity, Relationship to Intervention, and Action Taken.
Severity is rated on a 0-4 scale:
0 = Absence of the symptom;
- = Occasional presence of the symptom;
- = Mild severity, no impairment to routine functioning;
- = Moderate severity, producing some impairment to routine functioning;
- = Severe, causing significant impairment or disability to routine functioning.
Measured: From enrollment to the end of treatment at 4 weeks
Event-related potential（ERP）
ERP data acquisition in the laboratory was performed using the Curry system with an internationally standard 64-channel electrode cap. The right mastoid (M2) served as the reference electrode. Electrodes were attached above and below the left orbit to record vertical electro-oculogram (VEOG), and electrodes were placed at the outer canthi of both eyes to record horizontal electro-oculogram (HEOG). ERP data acquisition commenced once all electrode impedances were reduced below 5 kΩ.
For ERP data analysis, the recorded signals were band-pass filtered between 0.1 Hz and 30 Hz and continuously sampled at 500 Hz. The data were segmented into epochs of 1700 ms duration, including a 200-ms pre-stimulus baseline period and a 1500-ms post-stimulus period. The peak amplitudes of ERP components were calculated separately for each experimental group.
Measured: From enrollment to the end of treatment at 4 weeks
Eye Movement（EM）
Participant Preparation: Adjust the chair height and chin rest so that the participant's horizontal line of sight aligns with the center of the screen or the center of the upper half of the screen. Adjust the orientation of the eye tracker using its mount to ensure the eye being tracked is centered in the image on the operator's monitor.
Calibration: Perform calibration using the eye tracker to ensure the participant's eye is within its field of view. Ensure accurate identification of the eye and corneal reflection points through automatic threshold adjustment or manual adjustment. Instruct the participant to fixate on calibration points displayed on the screen to begin the calibration process.
Data Recording: Once calibration is successful, begin presenting the stimulus materials and recording the data.
Data Saving: Upon completion of the experiment, the data will be automatically saved to the designated folder.
Measured: From enrollment to the end of treatment at 4 weeks
Pulse diagnosis data
Participant Preparation: Ensure the participant is seated comfortably with their arm extended level with the heart, wrist straight, palm facing upwards. Place a fabric cushion under the wrist joint (dorsal side).
Device Connection: A Traditional Chinese Medicine (TCM) practitioner determines the Guan pulse position. Connect the sensor to this location.
Data Recording: The operator uses the software to record the participant's pulse pattern in a resting state. A typical recording duration is 1 minute.
Data Saving: Upon completion of the experiment, the data will be automatically saved to the designated folder.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048938
- Sponsor's protocol ID
- 2024-100R
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
- ClinicalTrials.gov ID
- NCT07048938
- Acronym / sponsor ID
- 2024-100R
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Concurrently receive antidepressant therapy with fluoxetine hydrochloride.
- 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)).
- Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication | Experimental | 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 | Combination Product: Five-Element Music 2 combined with antidepressant medication |
| health control | Other | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five-Element Music 1 combined with antidepressant medicationThe 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 1 Primarily in Gong and Zhi modes combined with antidepressant medication |
| Five-Element Music 2 combined with antidepressant medicationThe 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 | Combination product | Five-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medication |
| No Intervention: Observational CohortNo intervention will be applied to healthy people | Other | health control |
Primary outcome
The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment
Time frame: From enrollment to the end of the treatment at 4 weeks
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
6 secondary outcomes
Hamilton Anxiety Rating Scale（HAMA）
Time frame: From enrollment to the end of treatment at 4 weeks
Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）
Time frame: From enrollment to the end of treatment at 4 weeks
Treatment Emergent Symptom Scale（TESS）
Time frame: From enrollment to the end of treatment at 4 weeks
Event-related potential（ERP）
Time frame: From enrollment to the end of treatment at 4 weeks
Eye Movement（EM）
Time frame: From enrollment to the end of treatment at 4 weeks
Pulse diagnosis data
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Five-Element Music 1 combined with antidepressant medication and Five-Element Music 2 combined with antidepressant medication in people with Depression Disorder and Depression Disorders, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment (time frame: From enrollment to the end of the treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.