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Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

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…

ClinicalTrials.gov IDNCT07247344

PhaseNot Applicable

Enrollment1000

SponsorJiangsu Province Nanjing Brain Hospital

Age10 Years

SexALL

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Conditions studied

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

About this study

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 outcomes

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

Eligibility information

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.

Study locations

210000, Nanjing, Jiangsu China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.