Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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.

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• 210000 — Nanjing

Identifiers

NCT: NCT07247344 · 81725005-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗