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This cohort study involves the dynamic collection of clinical information from adolescent patients with major depressive episodes (including both major depressive disorder and bipolar disorder), encompassing serum parameters, physiological-behavioral signals, neuroimaging data, and neuropsychological scales. The study aims to summarize the comprehensive clinical characteristics of this population, identify new risk factors, and establish multivariate predictive models for treatment response, cognitive and emotional impairments. Furthermore, this research will thoroughly investigate the underlying neural mechanisms linking clinical manifestations and neuroimaging features in major depressive episodes.
Research Objectives：
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | The diagnosis of Major Depressive Episode will be made according to the DSM-4 criteria. Neuroimaging assessment will be performed following standardized MRI quality control and interpretation procedures, jointly evaluated by an experienced radiologist and psychiatrist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection and follow-up | Other | Main measures and data collection methods:
|
| Measure | Description | Time Frame |
|---|---|---|
| The 17-item Hamilton Depression Rating Scale (HAMD-17) | The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression. | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| Change in brain functional connectivity measured by resting-state functional MRI | Resting-state functional magnetic resonance imaging (rs-fMRI) will be employed to evaluate functional connectivity alterations in core brain networks | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| Change in Heart Rate Variability (HRV) via wearable device | Change in HRV derived from interbeat intervals (IBIs) collected via wearable device. | Within 4 weeks, but not exceeding 1 year. |
| Change in daily step count and activity patterns recorded via wearable device | Change in daily step count and overall activity patterns automatically recorded via wearable device. | Within 4 weeks, but not exceeding 1 year. |
| Change in Cytokines (reported in pg/mL) | Peripheral blood biomarkers will be measured to evaluate inflammatory and immune responses to treatment. Interferon-α (IFN-α) Interferon-γ (IFN-γ) Interleukin-1β (IL-1β) Interleukin-2 (IL-2) Interleukin-4 (IL-4) Interleukin-5 (IL-5) Interleukin-6 (IL-6) Interleukin-8 (IL-8) Interleukin-10 (IL-10) Interleukin-17 (IL-17) Tumor necrosis factor-alpha (TNF-α) | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| Change in Composite Immune-Inflammatory Ratio Index (unitless) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in electroencephalographic (EEG) activity measured by resting-state EEG | EEG recordings will be obtained before and after the treatment to evaluate changes in neural oscillatory activity and functional connectivity, including metrics such as power spectral density (alpha, beta bands), coherence, and event-related potentials. | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The study will recruit participants aged 10-20 years diagnosed with major depressive disorder (MDD) or bipolar disorder (BD) according to DSM-IV criteria. Diagnoses will be confirmed using SCID-I (age ≥18) or K-SADS-PL (age <18).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zexin Lin | Contact | 86-13906900678 | zexinlin@stu.njmu.edu.cn | |
| Jia Duan | Contact | 86-025-83295957 | jia_duan@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Fei Wang | the Affiliated Nanjing Brain Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 210000 | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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This composite index includes platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-HDL cholesterol ratio (MHR), which together reflect systemic inflammatory activity and immune status. |
| at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) | The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) | MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression. | at baseline, week 1, week 2, week 4, week 24, and up to 1 year |
| The Young Mania Rating Scale (YMRS) | he Young Mania Rating Scale (YMRS) is an 11-item clinician-rated scale used to assess the severity of manic symptoms. Each item is scored from 0 to 4 or 0 to 8, depending on symptom intensity, with a total score ranging from 0 to 60. Higher scores indicate more severe manic symptoms. A score below 12 is generally considered to reflect remission or minimal symptoms. | at baseline, week 1, week 2, week 4, week 24, and up to 1 year. |
| Change in Blood Oxygen Saturation | Change in continuously monitored SpO₂ values from wearable sensors. | Within 4 weeks, but not exceeding 1 year. |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |