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NCT Number: NCT07744490

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

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: From baseline through 24 months

    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).

Secondary outcomes

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

    Time frame: From baseline through 24 months

    Time from baseline to the first follow-up assessment at which a participant meets the diagnostic criteria for any target disorder, as determined using the K-SADS-PL.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Wang, PhD, MD

CONTACT

[email protected]

+8634773516

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Fudan University
  • Southeast University, China

Registry information

Official study title

A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents

Acronym: TRACE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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