CClinicalTrials.gg
Not yet recruitingNCT07744490TRACEUpdated Aug 4, 2026

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

An observational study in High Risk, Depression / Major Depressive Disorder and Anxiety Disease, sponsored by Shanghai Mental Health Center. Not yet recruiting at 1 site in China. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Shanghai Mental Health Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • children and adolescence
  • pediatric
  • high risk
  • mental disease
03

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Aged 7-17 years at enrollment.
  2. 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.
  3. 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.
  4. Willing and able to participate in the scheduled assessments and follow-up visits.
  5. Written informed consent provided by a parent or legal guardian and assent provided by the participant

Exclusion criteria

Exclusion Criteria:

  1. A current or previous diagnosis of a depressive disorder, anxiety disorder, or obsessive-compulsive disorder.
  2. A severe psychiatric condition requiring immediate clinical intervention, including acute suicide risk, a psychotic disorder, or a bipolar disorder.
  3. A major neurological disorder, severe head injury, or serious or unstable medical condition that may interfere with study participation.
  4. Intellectual or cognitive impairment that prevents the participant from understanding or completing the study assessments.
  5. Inability or unwillingness of the participant or legal guardian to comply with the study procedures.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

05

What researchers measure

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).

    Time frame: From baseline through 24 months

Secondary outcomes

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

    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.

    Time frame: From baseline through 24 months

06

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, 200030, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07744490
Lead sponsor
Shanghai Mental Health Center
Collaborators
Fudan University, Southeast University, China
Responsible party
Zhen Wang (vice-president, Shanghai Mental Health Center) — Principal investigator
First posted
Aug 4, 2026
Start date
Jul 25, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Aug 4, 2026

Study contacts

Zhen Wang, PhD, MD
Contact
wangzhen@smhc.org.cn
+8634773516
Zhen Wang
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion