Clinical High-riskNCT04509778
Develop a Psychosis Risk Calculator for Chinese Mental Health Servises
An observational study of Clinical High-risk, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This project will use the collected clinical and biological information of high-risk groups, use embedded computer chips, and use big data background analysis system to comprehensively evaluate the risk of high-risk groups, and build a mental illness risk estimator completely relying on the sample data of Chinese… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Clinical High-risk
- What is being tested?
- routine clinical treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Dec 2017
- 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 14 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.
Who cannot join
- Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders will be excluded;
- 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;
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- 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.
About this study
This project will use the collected clinical and biological information of high-risk groups, use embedded computer chips, and use big data background analysis system to comprehensively evaluate the risk of high-risk groups, and build a mental illness risk estimator completely relying on the sample data of Chinese population and with independent intellectual property rights.
The calculator function and the risk calculation standard verified by the model can obtain the risk degree of each patient's progress to psychosis in the next two years. This calculator will play an important role in the prevention and treatment of psychosis.
Read the detailed description
Severe mental disorders, mainly schizophrenia (SZ), affect 16 million Chinese population. At present, due to the lack of effective techniques and standards for early risk identification, the intervention opportunity for prevention and optimal efficacy is often missed.
In previous cohort studies , it has been found that this clinical high-risk(CHR) population can be effectively identified before its onset. Since 2011, the project team has been relying on the ShangHai At Risk for Psychosis Program, 300 CHRs were enrolled in the clinic through screening and diagnostic interview. The baseline clinical and event-related EEG indicators of this cohort were collected. The cohort was followed up for 2 years, with a follow-up completion rate of nearly 90%, it was found that the clinical outcome of high-risk groups was nearly one third, and the proportion of patients would be converted to schizophrenia within 2 years. This conversion rate is very consistent with the results of cohort studies of other large high-risk groups in the world. In view of this conversion ratio, many countries, such as the United States, have begun to use the baseline information to build prediction models, so as to form a psychiatric prediction tool.
After 5 years of accumulation, the project team has sufficient data to build a psychosis risk prediction model suitable for Chinese people, truly realize the goal of early diagnosis and treatment, and further support with the integration of key identification technologies and big data calculation.
- Conditions
- Clinical High-risk
- Being tested
- routine clinical treatment
- Keywords
- calculator; conversion
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 |
|---|---|---|
| SHARP | ShangHai At Risk for Psychosis Receives: Other: routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to psychosis
It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.
Measured: 4 weeks
Poor function
It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Dec 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical 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
- 200 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509778
- Sponsor's protocol ID
- 16CR3016A
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop a Psychosis Risk Calculator for Chinese Mental Health Servises
- ClinicalTrials.gov ID
- NCT04509778
- Acronym / sponsor ID
- 16CR3016A
- Conditions
- Clinical High-risk
- Keywords
- calculator; conversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 12 Aug 2020 (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 will use the collected clinical and biological information of high-risk groups, use embedded computer chips, and use big data background analysis system to comprehensively evaluate the risk of high-risk groups, and build a mental illness risk estimator completely relying on the sample data of Chinese population and with independent intellectual property rights.
The calculator function and the risk calculation standard verified by the model can obtain the risk degree of each patient's progress to psychosis in the next two years. This calculator will play an important role in the prevention and treatment of psychosis.
Detailed description
Severe mental disorders, mainly schizophrenia (SZ), affect 16 million Chinese population. At present, due to the lack of effective techniques and standards for early risk identification, the intervention opportunity for prevention and optimal efficacy is often missed.
In previous cohort studies , it has been found that this clinical high-risk(CHR) population can be effectively identified before its onset. Since 2011, the project team has been relying on the ShangHai At Risk for Psychosis Program, 300 CHRs were enrolled in the clinic through screening and diagnostic interview. The baseline clinical and event-related EEG indicators of this cohort were collected. The cohort was followed up for 2 years, with a follow-up completion rate of nearly 90%, it was found that the clinical outcome of high-risk groups was nearly one third, and the proportion of patients would be converted to schizophrenia within 2 years. This conversion rate is very consistent with the results of cohort studies of other large high-risk groups in the world. In view of this conversion ratio, many countries, such as the United States, have begun to use the baseline information to build prediction models, so as to form a psychiatric prediction tool.
After 5 years of accumulation, the project team has sufficient data to build a psychosis risk prediction model suitable for Chinese people, truly realize the goal of early diagnosis and treatment, and further support with the integration of key identification technologies and big data calculation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHARP | – | Other: routine clinical treatmentShangHai At Risk for Psychosis |
Who may qualify
- Ages
- 14 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 (5 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 (9 listed)
- Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders will be excluded;
- 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;
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 | SHARP |
Primary outcome
Conversion to psychosis
Time frame: 4 weeks
It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.
Poor function
Time frame: 4 weeks
It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clinical High-risk, 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 5 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: finished, as of the sponsor's last update on 12 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to psychosis (time frame: 4 weeks). 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 12 Aug 2020.