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
Sex
ALL
Min age
10 Years
Max age
20 Years
Healthy volunteers
No
Inclusion Criteria:
* Between 10 and 20 years of age;
* Diagnosis of major depressive disorder (MDD) or bipolar disorder (BD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Diagnosis is assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) for participants aged ≥18 years, or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) for participants aged \<18 years;
* Current moderate to severe depressive episode, defined as Hamilton Depression Rating Scale (HAMD) score ≥17;
* Participants and 1 or 2 parents (patients' age\< 18 years old) provide informed consent after the detailed description of the study.
Exclusion Criteria:
* Prior treatment with repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), electroconvulsive therapy (ECT), or standard psychological therapy within 6 months prior to screening;
* Comorbidity with other DSM-IV Axis I disorders or personality disorders;
* Judged clinically to be at serious risk of suicide;
* Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;
* Unstable medical conditions, e.g., severe asthma; Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;
* Mental retardation or autism spectrum disorder;
* Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
* Current drug or alcohol abuse or dependence;
* Pregnant or lactating females.
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)
Facility
City
Region
Status
210000
Nanjing
Jiangsu
Recruiting
More Jiangsu Province Nanjing Brain Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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