The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
1 other identifier
interventional
110
1 country
1
Brief Summary
This is a 49 weeks open-label randomized controlled study. Patients with schizophrenia and violence risk will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Subjects in control group will be treated and cared as usual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
May 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedAugust 2, 2019
August 1, 2019
2.3 years
February 2, 2018
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Violence Risk Assessment For Psychiatric Patients
The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients during 49 weeks treatment
49 Weeks
Modified Overt Aggression Scale (MOAS)
Score change of Modified Overt Aggression Scale (MOAS ). MOAS is used to assess aggressive behavior of psychosis patients. Including Verbal aggressive, aggressive to property, aggressive to self, aggressive to others, and total score. Each domain with score 0 to 4, total weighted score 0 to 40
49 Weeks
Secondary Outcomes (13)
Health economic evaluation
49 Weeks
Positive and Negative Syndrome Scale (PANSS)
49 Weeks
Hospitalization frequency
49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
49 Weeks
- +8 more secondary outcomes
Study Arms (2)
LAT-treated Community Model
EXPERIMENTALThe subjects in experimental group are on 'LAT-treated Community Model'. which means,beside care as usual, subjects will be treated by paliperidone palmitate, Psychiatrists will guide community mental health professinals about the treatment and management. Psychiatrists will give community mental health professinals and patients/ caregiver long acting injection related education information.
Care as usual
OTHERThe subjects in control group are on " cared as usual" Which means Patients will be managed follow the request of National Continuing Management and Intervention Program for Psychoses. Patients will managed by community mental health professionals, get education information and rehablitation guidence from them.
Interventions
The subjects in experimental group is on 'LAT-treated Community Model'. which means,beside care as usual, subjects will be treated by paliperidone palmitate, Psychiatrists will guide community mental health professinals about the treatment and management. Psychiatrists will give community mental health professinals and patients/ caregiver long acting injection related education information.
Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
Eligibility Criteria
You may qualify if:
- Diagnosed as schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V)
- Had violent behavior such as smashing or breaking, threatening with a weapon, committing arson or explosion in the past one year, whether the behavior can be stopped by persuading or not;
- Living with a guardian or a caregiver;
- Informed consent from the patients or their guardians;
- Resulted negative in urine pregnancy test if female at their reproductive age; female subjects must take effective measures to prevent pregnancy during the whole study or have been postmenopausal.-
You may not qualify if:
- Patients who have had suicidal ideation or suicidal attempts within 12 months before screening or in screening period;
- Intravenous drug abuse or Opioid dependence within 3 months before screening;
- Patients with treatment-resistant schizophrenia;
- Large dose of Clozapine (≥200mg/day) or other long-acting injectable antipsychotics used within 3 months or within 2 drug half-life periods before screening;
- Patients with any severe or unstable cardiovascular, respiratory, nervous system or other system diseases; clinically significant abnormality in laboratory examinations or ECG;
- Communication difficulties caused by cognitive impairment or unable to complete the assessments in the study;
- Patients assessed as unsuitable for the study in other reasons, such as allergic or intolerant to risperidone or paliperidone, resistant to risperidone or paliperidone (ineffective after adequate dosage and duration in medical history); unable to provide informed consent; historical treatments which might effect the results of the study; historical neuroleptic malignant syndrome or tardive dyskinesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Li MD, PhDlead
Study Sites (1)
Wuhan mental health center
Wuhan, Wuhan, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yi Li, Doctor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor would not known the arm, and forbiden to ask and comminicate with patients about the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research clinician
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 15, 2018
Study Start
May 5, 2018
Primary Completion
September 1, 2020
Study Completion
October 1, 2020
Last Updated
August 2, 2019
Record last verified: 2019-08