NCT07247344

Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Jiangsu Province Nanjing Brain Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Adolescent
• Major Depressive Disorder (MDD
• Bipolar Disorder (BD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: China