Multimodal phenotyping in adolescents hospitalized for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 210000
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zexin Lin
• Email: zexinlin@stu.njmu.edu.cn
• Phone: 86-13906900678

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.