Observational Study of Multimodal Biomarkers and Digital Phenotyping in Adolescents Aged 10 to 20 With Major Depressive and Bipolar Disorders

What this Trial Is About

Researchers are conducting an observational cohort study to collect detailed clinical information from adolescents aged 10 to 20 years who are experiencing major depressive episodes, including both major depressive disorder and bipolar disorder. The study aims to describe the clinical characteristics of this group, identify new risk factors, and create predictive models for treatment response and cognitive or emotional difficulties. It also explores the neural mechanisms connecting clinical symptoms and brain imaging findings in these depressive episodes. Participants undergo multiple assessments including clinical evaluations, physiological and behavioral monitoring, neuroimaging, and biomarker collection. Data collected include demographic and clinical information, multimodal MRI scans, heart rate variability, electroencephalography, emotion-related questionnaires, cognitive tests, wearable device behavioral data, and blood samples. Diagnoses are made according to DSM-IV criteria, with neuroimaging reviewed by specialists. Follow-up assessments occur at baseline, weeks 1, 2, 4, 24, and up to one year. During the study, participants will have repeated evaluations of depression severity using the Hamilton Depression Rating Scale and other scales, brain functional connectivity via resting-state fMRI, heart rate variability, activity patterns, blood cytokines, immune-inflammatory markers, EEG activity, and oxygen saturation. These measures track changes over time to better understand treatment response and disease progression. The study involves continuous monitoring using wearable devices and blood tests, lasting up to one year from enrollment.

Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study