Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

Официальное название

Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study

Обзор

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.

Подробное описание

Research Objectives：

1. 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. 2. 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. 3. 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. 4. 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.

Вмешательства

• Другое 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.

Первичные конечные точки

• The 17-item Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: 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 [Срок оценки: at baseline, week 1, week 2, week 4, week 24, and up to 1 year]
• Change in Heart Rate Variability (HRV) via wearable device [Срок оценки: Within 4 weeks, but not exceeding 1 year.]
• Change in daily step count and activity patterns recorded via wearable device [Срок оценки: Within 4 weeks, but not exceeding 1 year.]
• Change in Cytokines (reported in pg/mL) [Срок оценки: at baseline, week 1, week 2, week 4, week 24, and up to 1 year]
• Change in Composite Immune-Inflammatory Ratio Index (unitless) [Срок оценки: at baseline, week 1, week 2, week 4, week 24, and up to 1 year]

Вторичные конечные точки (5)

• Change in electroencephalographic (EEG) activity measured by resting-state EEG [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: at baseline, week 1, week 2, week 4, week 24, and up to 1 year]
• The Young Mania Rating Scale (YMRS) [Срок оценки: at baseline, week 1, week 2, week 4, week 24, and up to 1 year.]
• Change in Blood Oxygen Saturation [Срок оценки: Within 4 weeks, but not exceeding 1 year.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• 210000 — Нанкин

Идентификаторы

NCT: NCT07247344 · 81725005-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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