NCT07247344Recruiting
Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study
Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
This cohort study involves the dynamic collection of clinical information from adolescent patients with major depressive episodes (including both major depressive disorder and bipolar disorder), encompassing serum parameters, physiological-behavioral signals, neuroimaging data, and neuropsychological scales. The study aims to summarize the comprehensive clinical characteristics of this population, identify new risk factors, and establish multivariate predictive models for treatment response, cognitive and emotional impairments. Furthermore, this research will thoroughly investigate the underlying neural mechanisms linking clinical manifestations and neuroimaging features in major depressive episodes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 1 Mar 2025
- Primary completion date
- Mar 2029
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT07247344
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Mar 2025 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
- Current drug or alcohol abuse or dependence;
Other illness
- Comorbidity with other DSM-IV Axis I disorders or personality disorders;
- 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;
Other
- Judged clinically to be at serious risk of suicide;
- Pregnant or lactating females.
Who the study is looking for
- 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.
Age in the registry: 10 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 210000 Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.