SchizophreniaNCT04520399
Prediction of Violent Behavior in Patients With Schizophrenia by Multimodal Machine Learning
An observational study of Schizophrenia and Violence, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Patients with schizophrenia have a higher risk of committing violent crimes than the general population, and the relative risk of violence against others is four times higher than the general population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Violence
- What is being tested?
- none intervention
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2020to Sep 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: A total of 200 schizophrenic patients were collected in Shanghai Mental Health Center. Through the assessment of violent behavior (MOAS scale + self-report), schizophrenic patients were divided into violent group and non-violent group.
Who may be able to join
- for violent group
- Inpatient or out-patient treatment;
- Junior high school education or above, eliminate mental retardation;
- 18-60 years old;
- Han, right-handed;
- Meet the diagnostic criteria of ICD-10 schizophrenia;
Show all 12Show fewer
- Self-report and confirmed by family members that violence occurred at least 2 times in the recent six months;
- In the recent half year, the revised Version of the weighted total score of The Explicit Attack Scale (MOAS) ≥4;
- Exclude severe heart, liver, kidney, blood, digestive and nervous system diseases;
- Willing to participate in this study and sign the informed consent. Inclusion criteria for non-violent patients
- 1) Schizophrenic patients treated in hospital or outpatient; 2) Junior high school education or above, eliminate mental retardation; 3) 18-60 years old; 4) Han, right-handed; 5) Meet the diagnostic criteria of ICD-10 schizophrenia; 6) Self-reported and confirmed by family members that no violence has occurred in the past six months; 7) within the past revisions explicit scale (MOAS) weighted total score ˂ 4 points; 8) Exclude severe heart, liver, kidney, blood, digestive and nervous system diseases; 9) Willing to participate in this study and sign the informed consent.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Patients with schizophrenia have a higher risk of committing violent crimes than the general population, and the relative risk of violence against others is four times higher than the general population. Violence is a major public health problem because it often leads to poor prognosis, readmission and stigma in patients with schizophrenia.
MRI studies on violent behavior in schizophrenia are relatively few. These studies have found that violence is primarily associated with dysfunction in the ventral prefrontal and temporal limbic systems. Structural MRI found that violent behavior in schizophrenia was associated with increased volume of white matter in caudate nucleus, left orbitofrontal gyrus and right orbitofrontal gyrus. However, the current research results in this field are uneven, the methods are not consistent, and there is a lack of breakthrough progress, which needs to be integrated and deepened urgently.
If the violent behavior of the patients with schizophrenia could be predicted by magnetic resonance imaging, it would be a revolutionary try. By doing so, the investigators can strengthen the treatment of these patients and reduce the occurrence of violence. Based on previous studies, the investigators believe that violent schizophrenics exhibit recognizable imaging characteristics under structural phase, resting state, negative emotional images and natural stimuli models. Anomalies in a particular mode may be subtle and difficult to identify, but when multiple different modes are integrated, a significant and characteristic set of imaging markers will be present. This study will use the multivariate model of machine learning method, detection brain activation patterns under different situations among patients with violence. The investigators are going to study imaging biomarkers, and try to predict the possibility of onset of violence among schizophrenia patients, thus reduce the risks of violence.
- Conditions
- Schizophrenia, Violence
- Being tested
- none intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
there is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| violence | Not described Receives: Other: none intervention | |
| non-violence | Not described Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI testing results
structural MRI data
Measured: Sep.2022
resting state MRI data
functional connections between brain regions
Measured: Sep.2020
functional MRI data
brain stimulation models while in a natural stimulus or watching affective pictures
Measured: Sep.2020
Integrated data
integrated MRI data from machine learning method
Measured: Sep.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520399
- Sponsor's protocol ID
- 20200498
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Violent Behavior in Patients With Schizophrenia by Multimodal Machine Learning
- ClinicalTrials.gov ID
- NCT04520399
- Acronym / sponsor ID
- 20200498
- Conditions
- Schizophrenia, Violence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 20 Aug 2020 (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.
Patients with schizophrenia have a higher risk of committing violent crimes than the general population, and the relative risk of violence against others is four times higher than the general population. Violence is a major public health problem because it often leads to poor prognosis, readmission and stigma in patients with schizophrenia.
MRI studies on violent behavior in schizophrenia are relatively few. These studies have found that violence is primarily associated with dysfunction in the ventral prefrontal and temporal limbic systems. Structural MRI found that violent behavior in schizophrenia was associated with increased volume of white matter in caudate nucleus, left orbitofrontal gyrus and right orbitofrontal gyrus. However, the current research results in this field are uneven, the methods are not consistent, and there is a lack of breakthrough progress, which needs to be integrated and deepened urgently.
If the violent behavior of the patients with schizophrenia could be predicted by magnetic resonance imaging, it would be a revolutionary try. By doing so, the investigators can strengthen the treatment of these patients and reduce the occurrence of violence. Based on previous studies, the investigators believe that violent schizophrenics exhibit recognizable imaging characteristics under structural phase, resting state, negative emotional images and natural stimuli models. Anomalies in a particular mode may be subtle and difficult to identify, but when multiple different modes are integrated, a significant and characteristic set of imaging markers will be present. This study will use the multivariate model of machine learning method, detection brain activation patterns under different situations among patients with violence. The investigators are going to study imaging biomarkers, and try to predict the possibility of onset of violence among schizophrenia patients, thus reduce the risks of violence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| violence | – | Other: none intervention |
| non-violence | – | Other: none intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 200 schizophrenic patients were collected in Shanghai Mental Health Center. Through the assessment of violent behavior (MOAS scale + self-report), schizophrenic patients were divided into violent group and non-violent group.
Key inclusion criteria (12 listed)
- for violent group
- Inpatient or out-patient treatment;
- Junior high school education or above, eliminate mental retardation;
- 18-60 years old;
- Han, right-handed;
Key exclusion criteria (0 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 |
|---|---|---|
| none interventionthere is no intervention in this study | Other | non-violence, violence |
Primary outcome
MRI testing results
Time frame: Sep.2022
structural MRI data
resting state MRI data
Time frame: Sep.2020
functional connections between brain regions
functional MRI data
Time frame: Sep.2020
brain stimulation models while in a natural stimulus or watching affective pictures
Integrated data
Time frame: Sep.2020
integrated MRI data from machine learning method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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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.
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 Schizophrenia and Violence, run by Shanghai Mental Health Center 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 12 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 20 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Qiao (13817615936 ext. 13817615936, qiaoyi2004@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI testing results (time frame: Sep.2022). The study lists 4 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 20 Aug 2020.