The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia

August 1, 2019 updated by: Yi Li MD, PhD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yi Li, Doctor
  • Phone Number: (+86)027-59372200
  • Email: psylee@163.com

Study Contact Backup

  • Name: BaoLiang Zhong, Doctor
  • Phone Number: (+86)027-85836687

Study Locations

  • China
    • Wuhan
      • Wuhan, Wuhan, China, 430000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LAT-treated Community Model
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.
Other: LAT-treated Community Model
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.
Other: Care as usual
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.
Other: care as usual
Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Violence Risk Assessment For Psychiatric Patients
Time Frame: 49 Weeks
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)
Time Frame: 49 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health economic evaluation
Time Frame: 49 Weeks
Self developed health economic questionnaire, including demography questions, income before and after schizophrenia onset, schizophrenia related direct and indirect cost
49 Weeks
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 49 Weeks
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).
49 Weeks
Hospitalization frequency
Time Frame: 49 Weeks
Hospitalization due to schizophrenia during 49 weeks
49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
Time Frame: 49 Weeks
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.
49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
Time Frame: 49 Weeks
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.
49 Weeks
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication
Time Frame: 49 weeks
The patients' VAS 100 score change. Patients rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
49 weeks
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
Time Frame: 49 weeks
The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.
49 weeks
Family Burden Scale of Diseases (FBS)
Time Frame: 49 Weeks
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.
49 Weeks
Personal and Social Performance Scale (PSP)
Time Frame: 49 Weeks
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
49 Weeks
Treatment Emergent Symptom Scale (TESS)
Time Frame: 49 Weeks
Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment. each item rate from 0( no) to 4 (heavy)
49 Weeks
Clinical laboratory examination
Time Frame: 49 weeks
Blood routine examination
49 weeks
Electrocardiogram (ECG)
Time Frame: 49 Weeks
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.
49 Weeks
Adverse events
Time Frame: 49 weeks
The frequency of adverse events in the treatment period
49 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yi Li MD, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yi Li, Doctor, Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WG17A002

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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