High-riskDPM-rBDNCT07031661
A Cohort Study of Disease Prediction Model for High-risk Population With Bipolar Disorder
An observational study of High-risk and Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Bipolar disorder (BD) is a serious, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- High-risk, Bipolar Disorder, Atypical Depression
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to Dec 2025
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. High-risk offsprings of parents with BD: health offsprings of patients with bipolar disorder; 2. Atypical depression: patients with atypical depression according to DSM-5; 3. Health control: Health individuals with age and gender matched with high-risk offsprings.
Who may be able to join
- High-risk offsprings of parents with BD: Aged 6-18 yrs, both male and female. Offsprings and parents can sign the writtened informed consent form. At least one of parents was diagnosed with bipolar disorder by two or more senior psychiatric doctor.
- Atypical depression: Aged 6-18 yrs, both male and female. Patients and parents can sign the writtened informed consent form. Patients was diagnosed with atypical depression by two or more senior psychiatric doctor according to DSM-5. The disease phase and treatment regime are unrestricted.
- Health control: health individuals with age and gender matched with high-risk offsprings, no psychiatric family history.
Who cannot join
- High-risk offsprings of parents with BD: HCL-32 total score > 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.
- Atypical depression: HCL-32 total score > 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc. Patients cormobid substance abuse or treated with MECT in recent half a year.
- Health control: Individuals with psychiatric family history, severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.
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
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jun Chen, Ph.D, +86 18017311373, doctorcj2010@gmail.com
Tao Yang, Ph.D, +86 15800579832, yangtaocomeon@163.com
About this study
Official title: The Establishment of Disease Prediction Model for High-risk Population With Bipolar Disorder Based on Multimodal Data: A Multicenter, Large Sample, Prospective Cohort Study
Bipolar disorder (BD) is a serious, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. This situation will seriously influence one's behaviour or thinking, cognitive, emotional, social and occupational function, causing the heavy burden of disease. But, early recognition and early diagnosis are difficult to achieve at present.
Based on the preliminary research results of the project team, it is found that BD can be identified early through specific dimensions, and early recognition is crucial for the prognosis of patients. The earlier the intervention for BD is implemented, the better the prognosis, especially the functional prognosis, but the difficulty lies in how to implement it. Establishing a high-quality clinical cohort of BD high-risk population is a necessary prerequisite. This study intends to establish a high-quality, large-sample cohort through multi-center, long-term and prospective cohort design and enroll 100 BD high-risk patients every year, a total of 400 cases in 4 years. The electronic mental health service platform will be used for ten years of intensive follow-up. Multi-modal data including clinical characteristics, genetic, cognitive, neuroimaging, sleep monitoring, eeg, eye movement, speech, facial expression and movement were collected to construct the database. On this basis, the interaction of biological factors, clinical risk factors, and environmental risk factors in the onset of BD is discussed to establish a big data prediction model for BD onset in high-risk populations. The effective subgroups of early intervention were analyzed and screened. An ethical and individualized prediction model of the effectiveness and safety of early intervention for the BD high-risk population was constructed.
It is hoped that the smooth implementation of this project can provide empirical evidence for the early identification, prevention and intervention of BD. To provide clinicians with real data-driven decision-making guidance to assist in selecting personalized and precise treatment; Ultimately promote the prognosis and functional recovery of BD patients.
- Conditions
- High-risk, Bipolar Disorder, Atypical Depression
- Being tested
- This was an observational study with no intervention.
- Keywords
- bipolar disorder, high-risk, offspring, atypical depression, cohort study, prediction model
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was an observational study with no intervention.Other
This was an observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| high-risk offsprings of patients with bipolar disorder (HR-BD) | the 6-18 years old health offsprings with at least one parent with bipolar disorder Receives: Other: This was an observational study with no intervention. | |
| patients with atypical depression | the 6-18 years old patients with atypical depression according to the criteria of DSM-5 Receives: Other: This was an observational study with no intervention. | |
| health control | health juveniles with age and gender matched with HR-BD Receives: Other: This was an observational study with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevelence of mental illnesses over time in all three groups.
The K-SADS-PL or SCID will be used to screen the mental illnesses of all three group. The cumulative prevelence of all follow-up points will be calculated.
Measured: 4 year, participants will be followed-up every one year.
The differences of developmental trajectory of brain structure and function between three groups.
All participants will complete the brain MRI scan every each year, which including structural MRI, resting-state and task functional MRI. The volume, thickness, Reho, attributes of structural and functional brain networks will be calculated and compared longitudinally.
Measured: 4 year, participants will be scaned every each year.
The differences of developmental trajectory of multi-model features between three groups.
The electroencephalogram (EEGs), eye movement, Polysomnography (PSG), voice, expression and gait movement will be recorded at baseline and annual follow-up period. The features of event-related potentials like N1 and P3, event-related spectral perturbation will be extracted from EEG. Saccadic latency, saccadic peak velocity, saccadic amplitude, saccade count, average fixation duration, total fixation duration, visit count, velocity gain, position gain of smooth tracking, accuracy and latency of visual search will be extracted from eye movement records. Total sleep time, sleep efficiency, sleep onset latency, rapid eye movement (REM) sleep latency, awakenings number, wake after sleep onset, number of microarousals, apnea-hypopnea index, time of REM sleep will be analyzed according to PSG. Formant frequency, intensity, bandwidth, Hammarberg Index, Mel-frequency cepstral coefficients (MFCC) will be acquired from voice data. The facial expression entropy and facial action units will be ca
Measured: 4 year, participants will be followed-up every one year.
Secondary outcomes (4)
The differences of developmental trajectory of cognitive function between three groups.
All participants will be assessed with Wechsler Intelligence Scale for Children (WISC-III) or Wechsler Adult Intelligence Scale (WAIS-III). The total score of WISC-III/WAIS-III and scores of sub-scales will be calculated. Different ranges of total score of WISC-III/WAIS-III imply corresponding intelligence level. Intelligence quotient follows a normal distribution among the general population, with a mean of 100 and a standard deviation of 15. The higher the total score, the better the cognitive function.
Measured: 4 year, participants will be followed-up every one year.
The differences of quality of sleep between three groups.
All participants will be assessed with Sleep Disturbance Scale for Children (SDSC)/Pittsburgh Sleep Quality Index (PSQI). The scores of total scale or subscales will be calculated. The potential range is 26-130 in SDSC and 1-21 in PSQI, the higher the worse of sleep quality.
Measured: 4 year, participants will be followed-up every one year.
The differences of quality of life between three groups.
All participants will be assessed with Quality of life scale for children and adolescents (QLSCA)/ World Health Organization Quality of Life - BREF (WHOQOL-BREF). The total score will be calculated. The potential range is 0-100 in WHOQOL-BREF, the higher the better quality of life.
Measured: 4 year, participants will be followed-up every one year.
The differences of genetic phenotypes and between three groups.
The peripheral blood samples of all participants will be collected at baseline and every year, which include 5ml anticoagulant blood sample with EDTA and 5ml procoagulant blood sample. Genotyping carried out using the Illumina Genome wide Asian Screening Array (ASA) Assay. SNP of ANK3、SCN2A、CACNA1C、KCNB1、TRANK1、NCAN、HOMER1 will be selected. New genes will also be detected by GWAS.
Measured: 4 year, participants will be followed-up every one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-riskStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Hongkou District, Shanghai Mental Health Center, Xuhui District, Children's Hospital of Fudan University, Peking University Sixth Hospital, Qingdao No. 7 People's Hospital, Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031661
- Sponsor's protocol ID
- CRC2021ZD01
- Other IDs
- CRC2021ZD01
- Acronym
- DPM-rBD
- Status last verified
- Apr 2025
- First submitted
- 17 Oct 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of Disease Prediction Model for High-risk Population With Bipolar Disorder Based on Multimodal Data: A Multicenter, Large Sample, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07031661
- Acronym / sponsor ID
- DPM-rBD / CRC2021ZD01
- Conditions
- High-risk, Bipolar Disorder, Atypical Depression
- Keywords
- bipolar disorder, high-risk, offspring, atypical depression, cohort study, prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Hongkou District, Shanghai Mental Health Center, Xuhui District, Children's Hospital of Fudan University, Peking University Sixth Hospital, Qingdao No. 7 People's Hospital, Nanjing Medical University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jun 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.
Bipolar disorder (BD) is a serious, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. This situation will seriously influence one's behaviour or thinking, cognitive, emotional, social and occupational function, causing the heavy burden of disease. But, early recognition and early diagnosis are difficult to achieve at present.
Based on the preliminary research results of the project team, it is found that BD can be identified early through specific dimensions, and early recognition is crucial for the prognosis of patients. The earlier the intervention for BD is implemented, the better the prognosis, especially the functional prognosis, but the difficulty lies in how to implement it. Establishing a high-quality clinical cohort of BD high-risk population is a necessary prerequisite. This study intends to establish a high-quality, large-sample cohort through multi-center, long-term and prospective cohort design and enroll 100 BD high-risk patients every year, a total of 400 cases in 4 years. The electronic mental health service platform will be used for ten years of intensive follow-up. Multi-modal data including clinical characteristics, genetic, cognitive, neuroimaging, sleep monitoring, eeg, eye movement, speech, facial expression and movement were collected to construct the database. On this basis, the interaction of biological factors, clinical risk factors, and environmental risk factors in the onset of BD is discussed to establish a big data prediction model for BD onset in high-risk populations. The effective subgroups of early intervention were analyzed and screened. An ethical and individualized prediction model of the effectiveness and safety of early intervention for the BD high-risk population was constructed.
It is hoped that the smooth implementation of this project can provide empirical evidence for the early identification, prevention and intervention of BD. To provide clinicians with real data-driven decision-making guidance to assist in selecting personalized and precise treatment; Ultimately promote the prognosis and functional recovery of BD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-risk offsprings of patients with bipolar disorder (HR-BD) | – | Other: This was an observational study with no intervention.the 6-18 years old health offsprings with at least one parent with bipolar disorder |
| patients with atypical depression | – | Other: This was an observational study with no intervention.the 6-18 years old patients with atypical depression according to the criteria of DSM-5 |
| health control | – | Other: This was an observational study with no intervention.health juveniles with age and gender matched with HR-BD |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. High-risk offsprings of parents with BD: health offsprings of patients with bipolar disorder; 2. Atypical depression: patients with atypical depression according to DSM-5; 3. Health control: Health individuals with age and gender matched with high-risk offsprings.
Key inclusion criteria (3 listed)
- High-risk offsprings of parents with BD: Aged 6-18 yrs, both male and female. Offsprings and parents can sign the writtened informed consent form. At least one of parents was diagnosed with bipolar disorder by two or more senior psychiatric doctor.
- Atypical depression: Aged 6-18 yrs, both male and female. Patients and parents can sign the writtened informed consent form. Patients was diagnosed with atypical depression by two or more senior psychiatric doctor according to DSM-5. The disease phase and treatment regime are unrestricted.
- Health control: health individuals with age and gender matched with high-risk offsprings, no psychiatric family history.
Key exclusion criteria (3 listed)
- High-risk offsprings of parents with BD: HCL-32 total score > 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.
- Atypical depression: HCL-32 total score > 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc. Patients cormobid substance abuse or treated with MECT in recent half a year.
- Health control: Individuals with psychiatric family history, severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.
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 |
|---|---|---|
| This was an observational study with no intervention.This was an observational study with no intervention. | Other | health control, high-risk offsprings of patients with bipolar disorder (HR-BD), patients with atypical depression |
Primary outcome
The prevelence of mental illnesses over time in all three groups.
Time frame: 4 year, participants will be followed-up every one year.
The K-SADS-PL or SCID will be used to screen the mental illnesses of all three group. The cumulative prevelence of all follow-up points will be calculated.
The differences of developmental trajectory of brain structure and function between three groups.
Time frame: 4 year, participants will be scaned every each year.
All participants will complete the brain MRI scan every each year, which including structural MRI, resting-state and task functional MRI. The volume, thickness, Reho, attributes of structural and functional brain networks will be calculated and compared longitudinally.
The differences of developmental trajectory of multi-model features between three groups.
Time frame: 4 year, participants will be followed-up every one year.
The electroencephalogram (EEGs), eye movement, Polysomnography (PSG), voice, expression and gait movement will be recorded at baseline and annual follow-up period. The features of event-related potentials like N1 and P3, event-related spectral perturbation will be extracted from EEG. Saccadic latency, saccadic peak velocity, saccadic amplitude, saccade count, average fixation duration, total fixation duration, visit count, velocity gain, position gain of smooth tracking, accuracy and latency of visual search will be extracted from eye movement records. Total sleep time, sleep efficiency, sleep onset latency, rapid eye movement (REM) sleep latency, awakenings number, wake after sleep onset, number of microarousals, apnea-hypopnea index, time of REM sleep will be analyzed according to PSG. Formant frequency, intensity, bandwidth, Hammarberg Index, Mel-frequency cepstral coefficients (MFCC) will be acquired from voice data. The facial expression entropy and facial action units will be ca
4 secondary outcomes
The differences of developmental trajectory of cognitive function between three groups.
Time frame: 4 year, participants will be followed-up every one year.
The differences of quality of sleep between three groups.
Time frame: 4 year, participants will be followed-up every one year.
The differences of quality of life between three groups.
Time frame: 4 year, participants will be followed-up every one year.
The differences of genetic phenotypes and between three groups.
Time frame: 4 year, participants will be followed-up every one 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 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 High-risk and Bipolar Disorder, run by Shanghai Mental Health Center 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 3 inclusion and 3 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 22 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevelence of mental illnesses over time in all three groups. (time frame: 4 year, participants will be followed-up every one year.). The study lists 3 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 22 Jun 2025.