Develop a Psychosis Risk Calculator for Chinese Mental Health Servises

NCT04509778 | Completed

• 1 other identifier: 16CR3016A
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Clinical High-risk

Keywords

calculator; conversion

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

SHARP

ShangHai At Risk for Psychosis

Other: routine clinical treatment

Interventions

routine clinical treatment OTHER

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.

SHARP

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)