- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042739
Early Identification and Predictive Parsing for High Risk Group of Schizophrenia
September 6, 2021 updated by: Wuhan Mental Health Centre
Early Identification and Predictive Parsing for High Risk Group of Schizophr
An accurate identification of individuals at ultra-high risk (UHR) based on psychometric tools to prospectively identify psychosis as early as possible is required for indicated preventive intervention.
The diagnostic comparability of several psychometric tools is unknown.
To address the psychometric comparability of the CAARMS, SIPS and BSABS for subjects who are the immediate family and three-generation blood kinship of patients with schizophrenia.
To verify the viability and reliability of the three instruments for these subjects.
subjects who all are immediate family and three-generation blood kinship of patients with schizophreniawere interviewed.
All the subjects were assessed for a UHR state by three psychometric tools including CAARMS, SIPS and BSABS.
The psychometric diagnosis results including at risk of psychosis (UHR+), not at risk of psychosis (UHR-), and Psychosis.
Demographic and clinical characteristics interviewed by these three instruments were also measured.
The inter-rater agreement was assessed for evaluation of the coherence of the three scales.
Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years were also recorded.There is good diagnostic agreement between the CAARMS, SIPS and BSABS towards identification of UHR subjects who are immediate family and three-generation blood kinship of patients with schizophrenia.
Also, these three instruments are reliable and valid for assessing and detecting at risk mental states in these subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
189
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430022
- Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All are immediate family and three-generation blood kinship of patients with schizophrenia diagnosed in Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology.
Subjects are recruited from Wuhan Mental Health Center who can be contacted by telephone or an internet homepage.
Description
Inclusion Criteria:
- all are immediate family and three-generation blood kinship of patients with schizophrenia
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The overall agreement percent
Time Frame: 2 years
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diagnostic comparison of CAARMS and SIPS, SIPS and BSABS, CAARMS and BSABS.
|
2 years
|
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the inter-rater reliability
Time Frame: 2 years
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Inter-rater correlation (ICC) coefficients of CAARMS, SIPS and BSABS subscales.
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2 years
|
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the transition rates of UHR+ to psychosis within 2 years
Time Frame: 2 years
|
Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years follow-up.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peng Wang, Master, Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 6, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ky2018.45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on High Risk Group of Schizophrenia
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Samik Pharmaceutical Co. Ltd.CompletedHealthyKorea, Republic of
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Medtronic - MITGCompleted
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