Mental DisorderNCT06511713
AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking
An observational study of Mental Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- routine clinical treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 30 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Help-seeking first-visit participants will be consecutively recruited from the Shanghai Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre. They will be screened for eligibility by their clinicians.
Who may be able to join
- be aged 14 to 45-year-old
- have had at least 6-years of primary education
- be drug-naïve
- be understanding the survey, be willing to enrol in the study and sign the informed consent
- Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome
- Meets ICD-11 diagnostic criteria for schizophrenia
Show all 9Show fewer
- Meets ICD-11 diagnostic criteria for mood disorders
- Meets ICD-11 diagnostic criteria for anxiety disorders
- Meets ICD-11 diagnostic criteria for neurocognitive disorders
Who cannot join
- Acute or chronic renal failure; liver cirrhosis or active liver diseases
- Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects
- Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L
- Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial
- Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial
- Stroke within the last month
- Participating in any clinical trial within 30 days before the baseline
- Other situations judged by the investigators not to be suitable for the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
TianHong Zhang, Doctor, 13127577024, zhang_tianhong@126.com
About this study
Official title: Artificial Intelligence-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Images and High-Speed Eye-Tracking Trajectories
This project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop models for the classification and early warning of common mental disorders. These models will assist clinicians in making objective diagnoses of common mental disorders and in predicting the risk of adverse outcomes, thereby addressing the significant technical bottleneck of the current lack of objective diagnostic and warning instruments for mental disorders.
Read the detailed description
The investigators have completed the construction of the eye-tracking diagnostic and warning system and have piloted the new system. The plan is to recruit 1,000 individuals at Clinical High Risk for Psychosis (CHR) for model validation of predictive outcomes, and 1,000 patients with common mental disorders for model validation of diagnostic classification. This cohort includes 300 patients with schizophrenia, 300 patients with affective disorders, 200 patients with anxiety disorders, and 200 patients with cognitive impairment in the elderly. The system will also directly connect with the investigators' previous research data collection system and be deployed in no fewer than one hospital's healthcare system. Additionally, variables that may affect the accuracy of results will be fine-tuned to ensure that the eye-tracking and fundus system more accurately reflects actual clinical conditions. The application of the system will revolve around a big data analysis platform and seamlessly integrate with the existing hospital information systems, designing real-time feedback report modules to assist clinicians in making objective diagnoses efficiently and effectively.
- Conditions
- Mental Disorder
- Being tested
- routine clinical treatment
- Keywords
- eye movement
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine clinical treatmentOther
Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.
| Study group | Role | What they receive |
|---|---|---|
| the Clinical High Risk for Psychosis (CHR) Group | Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfill at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome Receives: Other: routine clinical treatment | |
| the Clinically Diagnosed Common Mental Disorders Group | 1,000 patients with common mental disorders, including 300 patients with schizophrenia, 300 patients with affective disorders, 200 patients with anxiety disorders, and 200 patients with cognitive impairment in the elderly. Receives: Other: routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye-tracking fixation point trajectory
Eye-tracking fixation point trajectory during free viewing of specific images by the participant (5 minutes)
Measured: 1 year
Fundus examination
Color fundus imaging collected by a digital fundus camera (Canon CR-2) under non-mydriatic conditions of the participant
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianhong ZHANG, Shanghai Mental Health Center
- Investigators
- TianHong Zhang, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511713
- Sponsor's protocol ID
- SHDC2022CRD026
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Images and High-Speed Eye-Tracking Trajectories
- ClinicalTrials.gov ID
- NCT06511713
- Acronym / sponsor ID
- SHDC2022CRD026
- Conditions
- Mental Disorder
- Keywords
- eye movement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (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 project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop models for the classification and early warning of common mental disorders. These models will assist clinicians in making objective diagnoses of common mental disorders and in predicting the risk of adverse outcomes, thereby addressing the significant technical bottleneck of the current lack of objective diagnostic and warning instruments for mental disorders.
Detailed description
The investigators have completed the construction of the eye-tracking diagnostic and warning system and have piloted the new system. The plan is to recruit 1,000 individuals at Clinical High Risk for Psychosis (CHR) for model validation of predictive outcomes, and 1,000 patients with common mental disorders for model validation of diagnostic classification. This cohort includes 300 patients with schizophrenia, 300 patients with affective disorders, 200 patients with anxiety disorders, and 200 patients with cognitive impairment in the elderly. The system will also directly connect with the investigators' previous research data collection system and be deployed in no fewer than one hospital's healthcare system. Additionally, variables that may affect the accuracy of results will be fine-tuned to ensure that the eye-tracking and fundus system more accurately reflects actual clinical conditions. The application of the system will revolve around a big data analysis platform and seamlessly integrate with the existing hospital information systems, designing real-time feedback report modules to assist clinicians in making objective diagnoses efficiently and effectively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Clinical High Risk for Psychosis (CHR) Group | – | Other: routine clinical treatmentThrough the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfill at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome |
| the Clinically Diagnosed Common Mental Disorders Group | – | Other: routine clinical treatment1,000 patients with common mental disorders, including 300 patients with schizophrenia, 300 patients with affective disorders, 200 patients with anxiety disorders, and 200 patients with cognitive impairment in the elderly. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Help-seeking first-visit participants will be consecutively recruited from the Shanghai Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre. They will be screened for eligibility by their clinicians.
Key inclusion criteria (9 listed)
- be aged 14 to 45-year-old
- have had at least 6-years of primary education
- be drug-naïve
- be understanding the survey, be willing to enrol in the study and sign the informed consent
- Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome
Key exclusion criteria (8 listed)
- Acute or chronic renal failure; liver cirrhosis or active liver diseases
- Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects
- Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L
- Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial
- Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial
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 |
|---|---|---|
| routine clinical treatmentParticipants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure. | Other | the Clinical High Risk for Psychosis (CHR) Group, the Clinically Diagnosed Common Mental Disorders Group |
Primary outcome
Eye-tracking fixation point trajectory
Time frame: 1 year
Eye-tracking fixation point trajectory during free viewing of specific images by the participant (5 minutes)
Fundus examination
Time frame: 1 year
Color fundus imaging collected by a digital fundus camera (Canon CR-2) under non-mydriatic conditions of the participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- 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. This study is not recruiting at the moment.
TianHong Zhang, Doctor principal investigator
Shanghai Mental Health Center
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 Mental 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TianHong Zhang, Doctor (13127577024, zhang_tianhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye-tracking fixation point trajectory (time frame: 1 year). The study lists 2 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 23 Jul 2024.