NCT04520399

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

August 13, 2020

Last Update Submit

August 18, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • MRI testing results

    structural MRI data

    Sep.2022

  • resting state MRI data

    functional connections between brain regions

    Sep.2020

  • functional MRI data

    brain stimulation models while in a natural stimulus or watching affective pictures

    Sep.2020

  • Integrated data

    integrated MRI data from machine learning method

    Sep.2020

Study Arms (2)

violence

Other: none intervention

non-violence

Other: none intervention

Interventions

there is no intervention in this study

non-violenceviolence

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • for violent group
  • Inpatient or out-patient treatment;
  • Junior high school education or above, eliminate mental retardation;
  • years old;
  • Han, right-handed;
  • Meet the diagnostic criteria of ICD-10 schizophrenia;
  • 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;
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 20, 2020

Study Start

October 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations