The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision 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. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time. The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Subjects in control group will be treated with oral antipsychotics or other conventional medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Apr 2017
Shorter than P25 for phase_4 schizophrenia
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
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 15, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 25, 2017
April 1, 2017
1 year
March 2, 2017
April 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Violence Risk Assessment For Severe Psychiatric Patients
The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients after 1-year treatment
1 year
Secondary Outcomes (13)
Modified Overt Aggression Scale (MOAS)
1 year
Health economic evaluation
1 year
Positive and Negative Syndrome Scale (PANSS)
1 year
Hospitalization frequency
1 year
WHO Quality of Life-BREF (WHOQOL-BREF)
1 year
- +8 more secondary outcomes
Study Arms (2)
paliperidone palmitate group
EXPERIMENTALThe subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement.
control group
ACTIVE COMPARATORThe subjects in control group will be applied with oral antipsychotics or other conventional medication.
Interventions
Subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement.
Subject in control group will be applied with oral antipsychotics or other conventional medication.
Eligibility Criteria
You may qualify if:
- Diagnosed as schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) and rated under 70 in PANSS;
- Had violent behavior such as smashing or breaking, threatening with a weapon, commiting 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
- Maosheng Fanglead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yi Lee, Doctor
Wuhan Mental Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research clinician
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 15, 2017
Study Start
April 1, 2017
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 25, 2017
Record last verified: 2017-04