210000
Nanjing, Jiangsu, China
Location status: Recruiting
Location contact
Fei Wang
CONTACT
Zexin Lin
CONTACT
NCT Number: NCT07247344
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.
Interested in participating?
Request Info10 year–20 year
All sexes
Observational
Nanjing, Jiangsu, China
Location status: Recruiting
Fei Wang
CONTACT
Zexin Lin
CONTACT
Research Objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Main measures and data collection methods:
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Resting-state functional magnetic resonance imaging (rs-fMRI) will be employed to evaluate functional connectivity alterations in core brain networks
Time frame: Within 4 weeks, but not exceeding 1 year.
Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.
Time frame: Within 4 weeks, but not exceeding 1 year.
Change in daily step count and overall activity patterns automatically recorded via wearable device.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Peripheral blood biomarkers will be measured to evaluate inflammatory and immune responses to treatment. Interferon-α (IFN-α) Interferon-γ (IFN-γ) Interleukin-1β (IL-1β) Interleukin-2 (IL-2) Interleukin-4 (IL-4) Interleukin-5 (IL-5) Interleukin-6 (IL-6) Interleukin-8 (IL-8) Interleukin-10 (IL-10) Interleukin-17 (IL-17) Tumor necrosis factor-alpha (TNF-α)
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
This composite index includes platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-HDL cholesterol ratio (MHR), which together reflect systemic inflammatory activity and immune status.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
EEG recordings will be obtained before and after the treatment to evaluate changes in neural oscillatory activity and functional connectivity, including metrics such as power spectral density (alpha, beta bands), coherence, and event-related potentials.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year.
he Young Mania Rating Scale (YMRS) is an 11-item clinician-rated scale used to assess the severity of manic symptoms. Each item is scored from 0 to 4 or 0 to 8, depending on symptom intensity, with a total score ranging from 0 to 60. Higher scores indicate more severe manic symptoms. A score below 12 is generally considered to reflect remission or minimal symptoms.
Time frame: Within 4 weeks, but not exceeding 1 year.
Change in continuously monitored SpO₂ values from wearable sensors.
Contact information is provided by the study sponsor or research team.
Jia Duan
CONTACT
Zexin Lin
CONTACT
Jiangsu Province Nanjing Brain Hospital
Other
Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
Acronym: MAPS-IO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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