High Risk Group of SchizophreniaNCT05042739
Early Identification and Predictive Parsing for High Risk Group of Schizophrenia
An observational study of High Risk Group of Schizophrenia, run by Wuhan Mental Health Centre at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- High Risk Group of Schizophrenia
- What is being tested?
- CAARMS;SIPS; BSABS;
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- all are immediate family and three-generation blood kinship of patients with schizophrenia
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022
About this study
Official title: 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.
- Conditions
- High Risk Group of Schizophrenia
- Being tested
- CAARMS;SIPS; BSABS;
- Keywords
- Psychosis; UHR; CAARMS;SIPS; BSABS
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAARMS;SIPS; BSABS;Diagnostic test
Comprehensive Assessment of At Risk Mental State (CAARMS); Structured Interview for Psychosis-Risk Syndrome (SIPS); Bonn Scale for the Assessment of Basic Symptoms (BSABS);
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall agreement percent
diagnostic comparison of CAARMS and SIPS, SIPS and BSABS, CAARMS and BSABS.
Measured: 2 years
the inter-rater reliability
Inter-rater correlation (ICC) coefficients of CAARMS, SIPS and BSABS subscales.
Measured: 2 years
the transition rates of UHR+ to psychosis within 2 years
Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 May 2017
- Primary completion1 Jan 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Group of SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Health Commission of Hubei Province
- Responsible party
- Sponsor
- Investigators
- Peng Wang, Master, Principal investigator, Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042739
- Sponsor's protocol ID
- ky2018.45
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Predictive Parsing for High Risk Group of Schizophr
- ClinicalTrials.gov ID
- NCT05042739
- Acronym / sponsor ID
- ky2018.45
- Conditions
- High Risk Group of Schizophrenia
- Keywords
- Psychosis; UHR; CAARMS;SIPS; BSABS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Wuhan Mental Health CentreUniversity, hospital or other
- Collaborators
- Health Commission of Hubei Province
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all are immediate family and three-generation blood kinship of patients with schizophrenia
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAARMS;SIPS; BSABS;Comprehensive Assessment of At Risk Mental State (CAARMS); Structured Interview for Psychosis-Risk Syndrome (SIPS); Bonn Scale for the Assessment of Basic Symptoms (BSABS); | Diagnostic test | – |
Primary outcome
The overall agreement percent
Time frame: 2 years
diagnostic comparison of CAARMS and SIPS, SIPS and BSABS, CAARMS and BSABS.
the inter-rater reliability
Time frame: 2 years
Inter-rater correlation (ICC) coefficients of CAARMS, SIPS and BSABS subscales.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for High Risk Group of Schizophrenia
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Wang, Master principal investigator
Dept. of Psychological Rehabilitation, Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Group of Schizophrenia, run by Wuhan Mental Health Centre at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall agreement percent (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.