Develop a Psychosis Risk Calculator for Chinese Mental Health Servises

Clinical High-risk Clinical Trial

Official title:

Develop a Psychosis Risk Calculator for Chinese Mental Health Servises

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509778
• Other study ID #: 16CR3016A
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2020
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Clinical High-risk
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks