High RiskTRACENCT07744490
Tracking Risk in Adolescents and Children for Early Identification of Common Mental Disorders
An observational study of High Risk and Depression / Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- High Risk, Depression / Major Depressive Disorder, Anxiety Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2026to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, 200030
Zhen Wang, PhD, MD, +8634773516, wangzhen@smhc.org.cn
About this study
Official title: A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents
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
- Medical subject headings
- Depression, Depressive Disorder, Major, Compulsive Personality Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start25 Jul 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High RiskStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Southeast University, China
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744490
- Sponsor's protocol ID
- SMHC-HRP-001
- Acronym
- TRACE
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents
- ClinicalTrials.gov ID
- NCT07744490
- Acronym / sponsor ID
- TRACE / SMHC-HRP-001
- Conditions
- High Risk, Depression / Major Depressive Disorder, Anxiety Disease, Obsessive - Compulsive Disorder
- Keywords
- children and adolescence, pediatric, high risk, mental disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Fudan University, Southeast University, China
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Time to Onset of a Depressive Disorder, Anxiety Disorder, or Obsessive-Compulsive Disorder
Time frame: From baseline through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen Wang principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk and Depression / Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, PhD, MD (+8634773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder (time frame: From baseline through 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.