Status:
COMPLETED
Develop a Psychosis Risk Calculator for Chinese Mental Health Servises
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Clinical High-risk
Eligibility:
All Genders
14-45 years
Brief 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 ri...
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 intervent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04509778
Start Date
December 1 2016
End Date
December 1 2017
Last Update
August 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Mental Health Center
Shanghai, China, 200030