About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Sponsors and contacts
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Shanghai Mental Health Center
Lead sponsor
Fudan University
Collaborator
Southeast University, China
Collaborator
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