Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

Condition(s) studied

Investigational drug(s) / intervention(s)

data collection and follow-up: Main measures and data collection methods: 1. Recording of baseline demographic and clinical information of the participants. 2. Multimodal magnetic resonance imaging. 3. Heart rate variability. 4. Electroencephalography. 5. Emotion-related questionnaires. 6. Cognitive tests. 7. Behavioral data collection using wearable devices. 8. Blood samples collection.

Study summary

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.

Eligibility

Primary outcome measure(s)

• The 17-item Hamilton Depression Rating Scale (HAMD-17) — at baseline, week 1, week 2, week 4, week 24, and up to 1 year
  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.
• Change in brain functional connectivity measured by resting-state functional MRI — at baseline, week 1, week 2, week 4, week 24, and up to 1 year
  Resting-state functional magnetic resonance imaging (rs-fMRI) will be employed to evaluate functional connectivity alterations in core brain networks
• Change in Heart Rate Variability (HRV) via wearable device — Within 4 weeks, but not exceeding 1 year.
  Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.
• Change in daily step count and activity patterns recorded via wearable device — Within 4 weeks, but not exceeding 1 year.
  Change in daily step count and overall activity patterns automatically recorded via wearable device.
• Change in Cytokines (reported in pg/mL) — at baseline, week 1, week 2, week 4, week 24, and up to 1 year
  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)
• Change in Composite Immune-Inflammatory Ratio Index (unitless) — at baseline, week 1, week 2, week 4, week 24, and up to 1 year
  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.

Trial sites (1)

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