Back to resultsThe Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paliperidone palmitate
control group
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) 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.
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
paliperidone palmitate group
control group
Arm Description
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.
The subjects in control group will be applied with oral antipsychotics or other conventional medication.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Modified Overt Aggression Scale (MOAS)
Patients' rated score in Modified Overt Aggression Scale after 1-year treatment
Health economic evaluation
The patients' and the caregivers' health economic questionnaire after 1-year treatment
Positive and Negative Syndrome Scale (PANSS)
PANSS total score after 6-month and 1-year treatment
Hospitalization frequency
Hospitalization frequency after 6-month and 1-year treatment
WHO Quality of Life-BREF (WHOQOL-BREF)
The patients' and the caregivers' WHOQOL-BREF score after 6-month and 1-year treatment
Visual Analogue Scale-100 (VAS 100)
The patients' and the caregivers' VAS 100 score after 6-month and 1-year treatment
Family Burden Scale of Diseases (FBS)
Family burden of the patient's family
Personal and Social Performance Scale (PSP)
PSP global score after 6-month and 1-year treatment
Treatment Emergent Symptom Scale (TESS)
Treatment Emergent Symptom Scale (TESS) score after 6-month and 1-year treatment
Vital signs
Heart rate and blood pressure after 6-month and 1-year treatment
Clinical laboratory examination
Blood routine examination after 6-month and 1-year treatment
Electrocardiogram (ECG)
Electrocardiogram (ECG) after 6-month and 1-year treatment
Adverse events
The frequency of adverse events in the treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03080194
Brief Title
The Effect of a Community-based LAI-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 1-year, Open-label Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maosheng Fang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
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 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.
Detailed Description
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, if they are able to use smart phones.
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. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement. Doctors have rights to decide whether a patient needs in-hospital treatment or extramural hospital treatment. The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate. Other medication or treatment measures should be decided according to doctors' clinical judgement and negotiation with patients and guardians.
Subjects in control group will be treated with oral antipsychotics or other conventional medication.
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
paliperidone palmitate group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The subjects in control group will be applied with oral antipsychotics or other conventional medication.
Intervention Type
Drug
Intervention Name(s)
paliperidone palmitate
Other Intervention Name(s)
Sustenna
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
Subject in control group will be applied with oral antipsychotics or other conventional medication.
Primary Outcome Measure Information:
Title
Violence Risk Assessment For Severe 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 after 1-year treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Modified Overt Aggression Scale (MOAS)
Description
Patients' rated score in Modified Overt Aggression Scale after 1-year treatment
Time Frame
1 year
Title
Health economic evaluation
Description
The patients' and the caregivers' health economic questionnaire after 1-year treatment
Time Frame
1 year
Title
Positive and Negative Syndrome Scale (PANSS)
Description
PANSS total score after 6-month and 1-year treatment
Time Frame
1 year
Title
Hospitalization frequency
Description
Hospitalization frequency after 6-month and 1-year treatment
Time Frame
1 year
Title
WHO Quality of Life-BREF (WHOQOL-BREF)
Description
The patients' and the caregivers' WHOQOL-BREF score after 6-month and 1-year treatment
Time Frame
1 year
Title
Visual Analogue Scale-100 (VAS 100)
Description
The patients' and the caregivers' VAS 100 score after 6-month and 1-year treatment
Time Frame
1 year
Title
Family Burden Scale of Diseases (FBS)
Description
Family burden of the patient's family
Time Frame
1 year
Title
Personal and Social Performance Scale (PSP)
Description
PSP global score after 6-month and 1-year treatment
Time Frame
1 year
Title
Treatment Emergent Symptom Scale (TESS)
Description
Treatment Emergent Symptom Scale (TESS) score after 6-month and 1-year treatment
Time Frame
1 year
Title
Vital signs
Description
Heart rate and blood pressure after 6-month and 1-year treatment
Time Frame
1 year
Title
Clinical laboratory examination
Description
Blood routine examination after 6-month and 1-year treatment
Time Frame
1 year
Title
Electrocardiogram (ECG)
Description
Electrocardiogram (ECG) after 6-month and 1-year treatment
Time Frame
1 year
Title
Adverse events
Description
The frequency of adverse events in the treatment period
Time Frame
1 year
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) 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.
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 Lee, Doctor
Phone
(+86)027-59372200
Email
psylee@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Zhou, Doctor
Phone
(+86)027-85836687
Email
wuhanzhouyang777@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Lee, Doctor
Organizational Affiliation
Wuhan Mental Health Centre
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia
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