Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study

NCT ID: NCT07247344

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2029-03-31

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.

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

data collection and follow-up

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Nanjing Brain Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fei Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Wang

Role: STUDY_CHAIR

the Affiliated Nanjing Brain Hospital, Nanjing Medical University

Locations

210000

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zexin Lin

Role: CONTACT

zexinlin@stu.njmu.edu.cn

86-13906900678

Jia Duan

Role: CONTACT

jia_duan@yeah.net

86-025-83295957

Facility Contacts

Fei Wang

Role: primary

fei.wang@yale.edu

86-025-83295957

Zexin Lin

Role: backup

zexinlin@stu.njmu.edu.cn

86-13906900678

Other Identifiers

81725005-11

Identifier Type: -

Identifier Source: org_study_id