Back to resultsThe Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LAT-treated Community Model
care as usual
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, violence risk, long-acting antipsychotics, community-based
Eligibility Criteria
Inclusion Criteria:
- 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.-
Exclusion Criteria:
- 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.
Sites / Locations
- Wuhan mental health centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
LAT-treated Community Model
Care as usual
Arm Description
The 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.
The 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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Health economic evaluation
Self developed health economic questionnaire, including demography questions, income before and after schizophrenia onset, schizophrenia related direct and indirect cost
Positive and Negative Syndrome Scale (PANSS)
PANSS score change. PANSS was used to assess schizophrenia psychopathology symptoms of subjects. PANSS gave a total score (total score of 30 items) and three subscale scores, positive subscale (7 items), negative subscale (7 items), general psychopathology symptoms subscale (16 items) . Each scale rated from 1 (none) to 7 (very heavy).
Hospitalization frequency
Hospitalization due to schizophrenia during 49 weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
The patients' WHOQOL-BREF score. The WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.
WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
The caregivers' WHOQOL-BREF score. WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication
The patients' VAS 100 score change. Patients rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
Family Burden Scale of Diseases (FBS)
Family burden of the patient's family. Including 26 items, score 0( no burden) to 2(heavy burden). Refer to family economy, family daily activities, family entertainment activities, family relationships, family member physical health and mental health.
Personal and Social Performance Scale (PSP)
PSP was a clinical scoring tool that was used for personal and social function assessment in schizophrenia subjects, and the score ranged between 1 and 100. The scale defined a continuous functional status, from overall function impaired (completely lack of independent basic functions, survival is significantly dangerous) to function well. The scale takes four functional dimensions into account: a) social useful activities, including work and study, b) the relationship between the individual and society, c) self-care, and d) disturbing and aggression
Treatment Emergent Symptom Scale (TESS)
Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment. each item rate from 0( no) to 4 (heavy)
Clinical laboratory examination
Blood routine examination
Electrocardiogram (ECG)
ECG testing should be performed in a quiet non-interference (such as TV, mobile) environment for the subjects. Before testing ECG the subjects should rest in the supine position for at least 5 minutes and should be limited to conversation or physical activity. Twelve-lead ECG was recorded by 25 mm/sec paper speed, measuring RR, PR, QRS and QT intervals.
Adverse events
The frequency of adverse events in the treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03434210
Brief Title
The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
Official Title
The Effect of a Community-based Long-acting Antipsychotic-treated Management Model on the Violence Risk of Patients With Schizophrenia: a 49 Weeks, Open-label Cluster Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Li MD, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a 49 weeks open-label,cluster 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. 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 per clinical judgement. For subjects who did not take risperidone, paliperidone extended release tablets, risperidone microspheres or paliperidone palmitate for injection previously, subjects should take oral paliperidone or risperidone sustained release tablets in the screening phase to perform ultra-sensitive test (the minimum dose of risperidone 1 mg/day and the minimum dose of sustained-release tablets paliperidone 3 mg/day, at least orally three days). Only subjects who were judged by the treating physician as tolerance to the drug could usepaliperidone palmitate .Suggest previous antipsychotics could be withdrawn within 4 weeks after first paliperidone palmitate administration , but will follow doctors' clinical judgement. The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate. Other medication or treatment measures should be decided by doctors' clinical judgement and align with patients and caregivers.Subjects in control group will be treated and cared as usual.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, violence risk, long-acting antipsychotics, community-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor would not known the arm, and forbiden to ask and comminicate with patients about the intervention.
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAT-treated Community Model
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Care as usual
Arm Type
Other
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
LAT-treated Community Model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
care as usual
Other Intervention Name(s)
Control group
Intervention Description
Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
Primary Outcome Measure Information:
Title
Violence Risk Assessment For Psychiatric Patients
Description
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
Time Frame
49 Weeks
Title
Modified Overt Aggression Scale (MOAS)
Description
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
Time Frame
49 Weeks
Secondary Outcome Measure Information:
Title
Health economic evaluation
Description
Self developed health economic questionnaire, including demography questions, income before and after schizophrenia onset, schizophrenia related direct and indirect cost
Time Frame
49 Weeks
Title
Positive and Negative Syndrome Scale (PANSS)
Description
PANSS score change. PANSS was used to assess schizophrenia psychopathology symptoms of subjects. PANSS gave a total score (total score of 30 items) and three subscale scores, positive subscale (7 items), negative subscale (7 items), general psychopathology symptoms subscale (16 items) . Each scale rated from 1 (none) to 7 (very heavy).
Time Frame
49 Weeks
Title
Hospitalization frequency
Description
Hospitalization due to schizophrenia during 49 weeks
Time Frame
49 Weeks
Title
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
Description
The patients' WHOQOL-BREF score. The WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.
Time Frame
49 Weeks
Title
WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
Description
The caregivers' WHOQOL-BREF score. WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.
Time Frame
49 Weeks
Title
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication
Description
The patients' VAS 100 score change. Patients rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
Time Frame
49 weeks
Title
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
Description
The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
Time Frame
49 weeks
Title
Family Burden Scale of Diseases (FBS)
Description
Family burden of the patient's family. Including 26 items, score 0( no burden) to 2(heavy burden). Refer to family economy, family daily activities, family entertainment activities, family relationships, family member physical health and mental health.
Time Frame
49 Weeks
Title
Personal and Social Performance Scale (PSP)
Description
PSP was a clinical scoring tool that was used for personal and social function assessment in schizophrenia subjects, and the score ranged between 1 and 100. The scale defined a continuous functional status, from overall function impaired (completely lack of independent basic functions, survival is significantly dangerous) to function well. The scale takes four functional dimensions into account: a) social useful activities, including work and study, b) the relationship between the individual and society, c) self-care, and d) disturbing and aggression
Time Frame
49 Weeks
Title
Treatment Emergent Symptom Scale (TESS)
Description
Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment. each item rate from 0( no) to 4 (heavy)
Time Frame
49 Weeks
Title
Clinical laboratory examination
Description
Blood routine examination
Time Frame
49 weeks
Title
Electrocardiogram (ECG)
Description
ECG testing should be performed in a quiet non-interference (such as TV, mobile) environment for the subjects. Before testing ECG the subjects should rest in the supine position for at least 5 minutes and should be limited to conversation or physical activity. Twelve-lead ECG was recorded by 25 mm/sec paper speed, measuring RR, PR, QRS and QT intervals.
Time Frame
49 Weeks
Title
Adverse events
Description
The frequency of adverse events in the treatment period
Time Frame
49 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.-
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li, Doctor
Phone
(+86)027-59372200
Email
psylee@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
BaoLiang Zhong, Doctor
Phone
(+86)027-85836687
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Li, Doctor
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Wuhan mental health center
City
Wuhan
State/Province
Wuhan
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongJie Zhou
Email
qingzh1108@126.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
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