Multimodal phenotyping in adolescents hospitalized for depression
Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
This project will collect brain scans, blood tests, sleep and activity signals, and psychological test results from hospitalized teens with major depressive episodes to try to find patterns that predict treatment response and cognitive or emotional problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 10 Years to 20 Years |
| Sex | All |
| Sponsor | Jiangsu Province Nanjing Brain Hospital Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07247344 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal observational cohort of adolescents aged 10–20 hospitalized for moderate to severe major depressive episodes (including MDD and bipolar disorder) that will collect serial clinical, serum biomarker, physiological-behavioral, neuropsychological, and neuroimaging data. Participants will undergo repeated assessments and follow-up to capture dynamic changes in mood, cognition, behavior, and biological signals during treatment. The study aims to summarize clinical and neuroimaging phenotypes, identify novel risk factors, and link clinical manifestations with brain features. Multivariate predictive models integrating the various data types will be developed to predict treatment response and cognitive-emotional outcomes.
Who should consider this trial
Good fit: Adolescents aged 10–20 hospitalized with a current moderate to severe major depressive episode (HAMD ≥17) diagnosed as MDD or bipolar disorder and able to provide informed consent (with parental consent for those under 18).
Not a fit: Patients who do not have a current moderate–severe depressive episode, are treated recently with certain brain stimulation or standard psychotherapy within 6 months, or who are not hospitalized or unable to complete imaging and biomarker procedures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could help clinicians predict which adolescents are likely to respond to treatment and tailor care based on combined clinical, biological, and imaging markers.
How similar studies have performed: Multimodal biomarker and predictive-model studies in adult depression have shown promising signals, but comparable longitudinal multimodal work specifically in adolescent inpatient populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 10 and 20 years of age; * Diagnosis of major depressive disorder (MDD) or bipolar disorder (BD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Diagnosis is assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) for participants aged ≥18 years, or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) for participants aged \<18 years; * Current moderate to severe depressive episode, defined as Hamilton Depression Rating Scale (HAMD) score ≥17; * Participants and 1 or 2 parents (patients' age\< 18 years old) provide informed consent after the detailed description of the study. Exclusion Criteria: * Prior treatment with repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), electroconvulsive therapy (ECT), or standard psychological therapy within 6 months prior to screening; * Comorbidity with other DSM-IV Axis I disorders or personality disorders; * Judged clinically to be at serious risk of suicide; * Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities; * Unstable medical conditions, e.g., severe asthma; Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases; * Mental retardation or autism spectrum disorder; * Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants); * Current drug or alcohol abuse or dependence; * Pregnant or lactating females.
Where this trial is running
Nanjing, Jiangsu
- 210000 — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zexin Lin
- Email: zexinlin@stu.njmu.edu.cn
- Phone: 86-13906900678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.