NCT07247344 Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study
| NCT ID | NCT07247344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiangsu Province Nanjing Brain Hospital |
| Condition | Adolescent |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-01 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Fei Wang
STUDY CHAIR
the Affiliated Nanjing Brain Hospital, Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07247344 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 20 Years, studying Adolescent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07247344 currently recruiting?
Yes, NCT07247344 is actively recruiting participants. Contact the research team at zexinlin@stu.njmu.edu.cn for enrollment information.
Where is the NCT07247344 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07247344 clinical trial?
NCT07247344 is sponsored by Jiangsu Province Nanjing Brain Hospital. The principal investigator is Fei Wang at the Affiliated Nanjing Brain Hospital, Nanjing Medical University. The trial plans to enroll 1,000 participants.