Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medication | Experimental |
| |
| Five-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medication | Active Comparator |
| |
| health control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Five-Element Music 1 combined with antidepressant medication | Combination 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Five-Element Music 2 combined with antidepressant medication | Combination 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 Cohort | Other | No intervention will be applied to healthy people |
|
| 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:
| 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;
| 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. | 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. | 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. | From enrollment to the end of treatment at 4 weeks |
| Jun 12, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Participants (Intervention Group) | May 15, 2025 | Jun 12, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Participants (Healthy Group) | May 15, 2025 | Jun 12, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided