An observational study in Clinical High-risk, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Shanghai Mental Health Center · Observational
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.
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 200 is above the median of 150 across 245 observational studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
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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.
Exclusion Criteria:
ShangHai At Risk for Psychosis
Other: routine clinical treatment
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.
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.
Time frame: 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.
Time frame: 4 weeks
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center