Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-20
SponsorJiangsu Province Nanjing Brain Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
The study will recruit participants aged 10-20 years diagnosed with major depressive disorder (MDD) or bipolar disorder (BD) according to DSM-IV criteria. Diagnoses will be confirmed using SCID-I (age ≥18) or K-SADS-PL (age \<18).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
data collection and follow-up
Other interventionMain 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: 11 intervention
Trial outcomes
Primary outcomes
1
The 17-item Hamilton Depression Rating Scale (HAMD-17)
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 year2
Change in brain functional connectivity measured by resting-state functional MRI
Resting-state functional magnetic resonance imaging (rs-fMRI) will be employed to evaluate functional connectivity alterations in core brain networks
Time frame
at baseline, week 1, week 2, week 4, week 24, and up to 1 year3
Change in Heart Rate Variability (HRV) via wearable device
Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.
Time frame
Within 4 weeks, but not exceeding 1 year.4
Change in daily step count and activity patterns recorded via wearable device
Change in daily step count and overall activity patterns automatically recorded via wearable device.
Time frame
Within 4 weeks, but not exceeding 1 year.Secondary outcomes
1
Change in electroencephalographic (EEG) activity measured by resting-state EEG
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 year2
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S)
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 year3
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)
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 year4
The Young Mania Rating Scale (YMRS)
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
at baseline, week 1, week 2, week 4, week 24, and up to 1 year.Sponsors and contacts
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Source ClinicalTrials.gov