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NCT07048938
Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
NA trial testing Five-Element Music 1 combined with antidepressant medication in Depression Disorder in 120 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | Shanghai Mental Health Center |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 July 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 March 2026 |
Drugs / interventions tested
- Five-Element Music 1 combined with antidepressant medication
- Five-Element Music 2 combined with antidepressant medication
- No Intervention: Observational Cohort — full drug profile →
Conditions studied
- Depression Disorder — all drugs for Depression Disorder →
- Depression Disorders — all drugs for Depression Disorders →
- Depressive Disorder — all drugs for Depressive Disorder →
Sponsor
Shanghai Mental Health Center — full company profile →
Who can join
Adults 18 to 60, any sex, with Depression Disorder or Depression Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07048938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Mental Health Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07048938 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
- Last refreshed: 3 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07048938.
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