Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

NCT07247344 | Recruiting

• 1 other identifier: 81725005-11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Major Depressive Episode

Outcome Measures

Primary Outcomes (6)

• The 17-item Hamilton Depression Rating Scale (HAMD-17)

  The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.

  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

  Resting-state functional magnetic resonance imaging (rs-fMRI) will be employed to evaluate functional connectivity alterations in core brain networks

  at baseline, week 1, week 2, week 4, week 24, and up to 1 year

• Change in Heart Rate Variability (HRV) via wearable device

  Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.

  Within 4 weeks, but not exceeding 1 year.

• Change in daily step count and activity patterns recorded via wearable device

  Change in daily step count and overall activity patterns automatically recorded via wearable device.

  Within 4 weeks, but not exceeding 1 year.

• Change in Cytokines (reported in pg/mL)

  Peripheral blood biomarkers will be measured to evaluate inflammatory and immune responses to treatment. Interferon-α (IFN-α) Interferon-γ (IFN-γ) Interleukin-1β (IL-1β) Interleukin-2 (IL-2) Interleukin-4 (IL-4) Interleukin-5 (IL-5) Interleukin-6 (IL-6) Interleukin-8 (IL-8) Interleukin-10 (IL-10) Interleukin-17 (IL-17) Tumor necrosis factor-alpha (TNF-α)

  at baseline, week 1, week 2, week 4, week 24, and up to 1 year

• Change in Composite Immune-Inflammatory Ratio Index (unitless)

  This composite index includes platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-HDL cholesterol ratio (MHR), which together reflect systemic inflammatory activity and immune status.

  at baseline, week 1, week 2, week 4, week 24, and up to 1 year

Secondary Outcomes (5)

• Change in electroencephalographic (EEG) activity measured by resting-state EEG

  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)

  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)

  at baseline, week 1, week 2, week 4, week 24, and up to 1 year

• The Young Mania Rating Scale (YMRS)

  at baseline, week 1, week 2, week 4, week 24, and up to 1 year.

• Change in Blood Oxygen Saturation

  Within 4 weeks, but not exceeding 1 year.

Study Arms (1)

1

The diagnosis of Major Depressive Episode will be made according to the DSM-4 criteria. Neuroimaging assessment will be performed following standardized MRI quality control and interpretation procedures, jointly evaluated by an experienced radiologist and psychiatrist.

Other: data collection and follow-up

Interventions

data collection and follow-up OTHER

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.

1

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit participants aged 10-20 years diagnosed with major depressive disorder (MDD) or bipolar disorder (BD) according to DSM-IV criteria. Diagnoses will be confirmed using SCID-I (age ≥18) or K-SADS-PL (age \<18).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

210000

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fei Wang

  the Affiliated Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Zexin Lin

CONTACT

86-13906900678; zexinlin@stu.njmu.edu.cn

Jia Duan

CONTACT

86-025-83295957; jia_duan@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)