Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The 17-item Hamilton Depression Rating Scale (HAMD-17)
研究概览
简要总结
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.
详细描述
Research Objectives：
- To conduct a longitudinal investigation in adolescent patients with major depressive episodes (including major depressive disorder and bipolar disorder) to observe the dynamic progression of cognitive function, emotional disorders, physiological-behavioral characteristics, and related contributing factors.
- To systematically explore and summarize the clinical, physiological-behavioral, and neuroimaging characteristics of adolescents with major depressive episodes, with the aim of identifying novel risk factors associated with treatment response and clinical outcomes.
- To perform an in-depth investigation into the underlying neurobiological mechanisms of major depressive episodes and examine the interrelationships between clinical manifestations, physiological-behavioral indicators, and neuroimaging outcomes.
- To develop a multifactorial predictive model for treatment response and cognitive-emotional impairments in major depressive episodes, integrating clinical, physiological-behavioral, neuroimaging, and biomarker data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The 17-item Hamilton Depression Rating Scale (HAMD-17)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- The Young Mania Rating Scale (YMRS)(at baseline, week 1, week 2, week 4, week 24, and up to 1 year.)
- Change in electroencephalographic (EEG) activity measured by resting-state EEG(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)(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)(at baseline, week 1, week 2, week 4, week 24, and up to 1 year)
- Change in Blood Oxygen Saturation(Within 4 weeks, but not exceeding 1 year.)
研究者
Fei Wang
Professor
Jiangsu Province Nanjing Brain Hospital