Tracking Risk in Adolescents and Children for Early Identification of Common Mental Disorders

NCT07744490 | Not Yet Recruiting

• 1 other identifier: SMHC-HRP-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study will enroll approximately 200 children and adolescents aged 7-17 years who are at elevated risk for common mental disorders, including depressive disorders, anxiety disorders, and obsessive-compulsive disorder, based on family history or subthreshold emotional or behavioral symptoms. Participants will be followed for two years. Clinical assessments, questionnaires, EEG, biological samples, and MRI will be collected at scheduled intervals. The study aims to identify factors associated with the onset and progression of these disorders and support early risk identification.

Conditions

High Risk; Depression / Major Depressive Disorder; Anxiety Disease; Obsessive - Compulsive Disorder

Keywords

children and adolescence; pediatric; high risk; mental disease

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder

  The proportion of participants who newly meet the diagnostic criteria for at least one depressive disorder, anxiety disorder, or obsessive-compulsive disorder during follow-up, as determined using the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

  From baseline through 24 months

Secondary Outcomes (1)

• Time to Onset of a Depressive Disorder, Anxiety Disorder, or Obsessive-Compulsive Disorder

  From baseline through 24 months

Study Arms (1)

Children and Adolescents at High Risk for Common Mental Disorders

Children and adolescents aged 7-17 years who are at elevated risk for depressive disorders, anxiety disorders, or obsessive-compulsive disorder because of a relevant family history or subthreshold emotional or behavioral symptoms. Participants will be followed prospectively for two years and will undergo scheduled clinical, psychological, neurophysiological, neuroimaging, and biological assessments. No intervention or treatment will be assigned as part of this observational study.

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 200 children and adolescents aged 7-17 years who are at elevated risk for depressive disorders, anxiety disorders, or obsessive-compulsive disorder will be enrolled. Elevated risk is defined by a relevant family history or clinically significant subthreshold emotional or repetitive behavioral symptoms. Participants will not meet the full diagnostic criteria for the target disorders at baseline and will be followed prospectively for two years.

You may qualify if:

• Aged 7-17 years at enrollment.
• Meeting at least one of the following conditions: Having at least one first-degree relative with a depressive disorder, anxiety disorder, or obsessive-compulsive disorder; or exhibiting clinically relevant but subthreshold depressive, anxiety, obsessive-compulsive, or repetitive behavioral symptoms.
• Not meeting the full diagnostic criteria for a depressive disorder, anxiety disorder, or obsessive-compulsive disorder at baseline, as assessed using the K-SADS-PL.
• Willing and able to participate in the scheduled assessments and follow-up visits.
• Written informed consent provided by a parent or legal guardian and assent provided by the participant

You may not qualify if:

• A current or previous diagnosis of a depressive disorder, anxiety disorder, or obsessive-compulsive disorder.
• A severe psychiatric condition requiring immediate clinical intervention, including acute suicide risk, a psychotic disorder, or a bipolar disorder.
• A major neurological disorder, severe head injury, or serious or unstable medical condition that may interfere with study participation.
• Intellectual or cognitive impairment that prevents the participant from understanding or completing the study assessments.
• Inability or unwillingness of the participant or legal guardian to comply with the study procedures.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Fudan University: collaborator
• Southeast University, China: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and stool samples will be retained, including genomic DNA extracted from peripheral blood and microbial DNA extracted from stool. These samples will be used to investigate genetic and gut microbiome factors associated with the onset and progression of depressive disorders, anxiety disorders, and obsessive-compulsive disorder.

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Compulsive Personality Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Personality Disorders

Study Officials

• Zhen Wang

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Wang, PhD, MD

CONTACT

+8634773516; wangzhen@smhc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)