AdolescentMAPS-IONCT07247344
Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study
An observational study of Adolescent and Major Depressive Disorder (MDD, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Adolescent, Major Depressive Disorder (MDD, Bipolar Disorder (BD)
- What is being tested?
- data collection and follow-up
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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).
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
- Current drug or alcohol abuse or dependence;
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
210000
Nanjing, Jiangsu
Fei Wang, 86-025-83295957, fei.wang@yale.edu
Zexin Lin, 86-13906900678, zexinlin@stu.njmu.edu.cn
About this study
Official title: Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
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.
Read the detailed description
Research Objectives：
- To conduct a longitudinal investigation in adolescent patients with major depressive episodes (including major depressive disorder and bipolar disorder) to observe the dynamic progression of cognitive function, emotional disorders, physiological-behavioral characteristics, and related contributing factors.
- To systematically explore and summarize the clinical, physiological-behavioral, and neuroimaging characteristics of adolescents with major depressive episodes, with the aim of identifying novel risk factors associated with treatment response and clinical outcomes.
- To perform an in-depth investigation into the underlying neurobiological mechanisms of major depressive episodes and examine the interrelationships between clinical manifestations, physiological-behavioral indicators, and neuroimaging outcomes.
- To develop a multifactorial predictive model for treatment response and cognitive-emotional impairments in major depressive episodes, integrating clinical, physiological-behavioral, neuroimaging, and biomarker data.
- Being tested
- data collection and follow-up
- Keywords
- Major Depressive Episode
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection and follow-upOther
Main measures and data collection methods:
- Recording of baseline demographic and clinical information of the participants.
- Multimodal magnetic resonance imaging.
- Heart rate variability.
- Electroencephalography.
- Emotion-related questionnaires.
- Cognitive tests.
- Behavioral data collection using wearable devices.
- Blood samples collection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The diagnosis of Major Depressive Episode will be made according to the DSM-4 criteria. Neuroimaging assessment will be performed following standardized MRI quality control and interpretation procedures, jointly evaluated by an experienced radiologist and psychiatrist. Receives: Other: data collection and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
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
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Change in Heart Rate Variability (HRV) via wearable device
Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.
Measured: Within 4 weeks, but not exceeding 1 year.
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.
Measured: Within 4 weeks, but not exceeding 1 year.
Change in Cytokines (reported in pg/mL)
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)
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Change in Composite Immune-Inflammatory Ratio Index (unitless)
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Secondary outcomes (5)
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
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.
Measured: at baseline, week 1, week 2, week 4, week 24, and up to 1 year.
Change in Blood Oxygen Saturation
Change in continuously monitored SpO₂ values from wearable sensors.
Measured: Within 4 weeks, but not exceeding 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Mar 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Wang, Jiangsu Province Nanjing Brain Hospital
- Investigators
- Fei Wang, Study chair, the Affiliated Nanjing Brain Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247344
- Sponsor's protocol ID
- 81725005-11
- Acronym
- MAPS-IO
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07247344
- Acronym / sponsor ID
- MAPS-IO / 81725005-11
- Keywords
- Major Depressive Episode
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Objectives：
- To conduct a longitudinal investigation in adolescent patients with major depressive episodes (including major depressive disorder and bipolar disorder) to observe the dynamic progression of cognitive function, emotional disorders, physiological-behavioral characteristics, and related contributing factors.
- To systematically explore and summarize the clinical, physiological-behavioral, and neuroimaging characteristics of adolescents with major depressive episodes, with the aim of identifying novel risk factors associated with treatment response and clinical outcomes.
- To perform an in-depth investigation into the underlying neurobiological mechanisms of major depressive episodes and examine the interrelationships between clinical manifestations, physiological-behavioral indicators, and neuroimaging outcomes.
- To develop a multifactorial predictive model for treatment response and cognitive-emotional impairments in major depressive episodes, integrating clinical, physiological-behavioral, neuroimaging, and biomarker data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: data collection and follow-upThe diagnosis of Major Depressive Episode will be made according to the DSM-4 criteria. Neuroimaging assessment will be performed following standardized MRI quality control and interpretation procedures, jointly evaluated by an experienced radiologist and psychiatrist. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection and follow-upMain 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. | Other | 1 |
Primary outcome
The 17-item Hamilton Depression Rating Scale (HAMD-17)
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.
Change in brain functional connectivity measured by resting-state functional MRI
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
Change in Heart Rate Variability (HRV) via wearable device
Time frame: Within 4 weeks, but not exceeding 1 year.
Change in HRV derived from interbeat intervals (IBIs) collected via wearable device.
Change in daily step count and activity patterns recorded 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.
Change in Cytokines (reported in pg/mL)
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)
Change in Composite Immune-Inflammatory Ratio Index (unitless)
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.
5 secondary outcomes
Change in electroencephalographic (EEG) activity measured by resting-state EEG
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S)
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year
The Young Mania Rating Scale (YMRS)
Time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year.
Change in Blood Oxygen Saturation
Time frame: Within 4 weeks, but not exceeding 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Adolescent
Active, not recruiting
EyeBreathe: A Mixed Reality Game With Eye Tracking and Breathing Biofeedback for Adolescent Basketball Players
Healthy Adolescents
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
Non-suicidal Self-injury (NSSI), Adolescent
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fei Wang study chair
the Affiliated Nanjing Brain Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent and Major Depressive Disorder (MDD, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zexin Lin (86-13906900678, zexinlin@stu.njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 17-item Hamilton Depression Rating Scale (HAMD-17) (time frame: at baseline, week 1, week 2, week 4, week 24, and up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 3 Nov 2026.