Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study (MAPS-IO)

Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort 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 emotional impairments. Furthermore, this research will thoroughly investigate the underlying neural mechanisms linking clinical manifestations and neuroimaging features in major depressive episodes.

Study Overview

• Status: Recruiting
• Conditions: Adolescent; Bipolar Disorder (BD); Major Depressive Disorder (MDD
• Intervention / Treatment: Other: data collection and follow-up

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jia Duan; Phone Number: 86-025-83295957; Email: jia_duan@yeah.net
• Study Contact Backup: Name: Zexin Lin; Phone Number: 86-13906900678; Email: zexinlin@stu.njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • 210000
      • Contact: Fei Wang; Phone Number: 86-025-83295957; Email: fei.wang@yale.edu
      • Contact: Zexin Lin; Phone Number: 86-13906900678; Email: zexinlin@stu.njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Main measures and data collection methods: Recording of baseline demographic and clinical information of the participants.; Multimodal magnetic resonance imaging.; Heart rate variability.; Electroencephalography.; Emotion-related questionnaires.; Cognitive tests.; Behavioral data collection using wearable devices.; Blood samples collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in electroencephalographic (EEG) activity measured by resting-state EEG	EEG recordings will be obtained before and after the treatment to evaluate changes in neural oscillatory activity and functional connectivity, including metrics such as power spectral density (alpha, beta bands), coherence, and event-related potentials.	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)	The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.	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)	MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.	at baseline, week 1, week 2, week 4, week 24, and up to 1 year
The Young Mania Rating Scale (YMRS)	he Young Mania Rating Scale (YMRS) is an 11-item clinician-rated scale used to assess the severity of manic symptoms. Each item is scored from 0 to 4 or 0 to 8, depending on symptom intensity, with a total score ranging from 0 to 60. Higher scores indicate more severe manic symptoms. A score below 12 is generally considered to reflect remission or minimal symptoms.	at baseline, week 1, week 2, week 4, week 24, and up to 1 year.
Change in Blood Oxygen Saturation	Change in continuously monitored SpO₂ values from wearable sensors.	Within 4 weeks, but not exceeding 1 year.

Collaborators and Investigators

• Sponsor: Jiangsu Province Nanjing Brain Hospital
• Investigators: Study Chair: Fei Wang, the Affiliated Nanjing Brain Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Major Depressive Episode
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: 81725005-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No