RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form after the detailed description of the study. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

data collection and follow-up

Main measures and data collection methods: 1. Recording of baseline demographic and clinical information of the participants. 2. Multimodal magnetic resonance imaging. 3. Heart rate variability. 4. Electroencephalography. 5. Emotion-related questionnaires. 6. Cognitive tests. 7. Behavioral data collection using wearable devices. 8. Blood samples collection.

Locations (1)

210000

Nanjing, Jiangsu, China