SchizophreniaNCT03434210
The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
A study testing LAT-treated Community Model and care as usual in people with Schizophrenia, run by Yi Li MD, PhD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LAT-treated Community Model and care as usual
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2018to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.-
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
BaoLiang Zhong, Doctor contact
China1 site, 1 recruiting
- Recruiting
Wuhan mental health center
Wuhan, Wuhan, 430000
YongJie Zhou, qingzh1108@126.com
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- LAT-treated Community Model, care as usual
- Keywords
- schizophrenia, violence risk, long-acting antipsychotics, community-based
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAT-treated Community ModelOther
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.
care as usualOther
Also called Control group
Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
| Study group | Role | What they receive |
|---|---|---|
| LAT-treated Community Model | Experimental | 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. Receives: Other: LAT-treated Community Model |
| Care as usual | Other | 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. Receives: Other: care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 49 Weeks
Secondary outcomes (13)
Health economic evaluation
Self developed health economic questionnaire, including demography questions, income before and after schizophrenia onset, schizophrenia related direct and indirect cost
Measured: 49 Weeks
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).
Measured: 49 Weeks
Hospitalization frequency
Hospitalization due to schizophrenia during 49 weeks
Measured: 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.
Measured: 49 Weeks
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.
Measured: 49 Weeks
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.
Measured: 49 weeks
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.
Measured: 49 weeks
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.
Measured: 49 Weeks
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
Measured: 49 Weeks
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)
Measured: 49 Weeks
Clinical laboratory examination
Blood routine examination
Measured: 49 weeks
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.
Measured: 49 Weeks
Adverse events
The frequency of adverse events in the treatment period
Measured: 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start5 May 2018
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Li MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Li MD, PhD, Huazhong University of Science and Technology
- Investigators
- Yi Li, Doctor, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434210
- Sponsor's protocol ID
- WG17A002
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03434210
- Acronym / sponsor ID
- WG17A002
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, violence risk, long-acting antipsychotics, community-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Yi Li MD, PhDUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAT-treated Community Model | Experimental | Other: LAT-treated Community ModelThe 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 | Other | Other: care as usualThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.-
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAT-treated Community ModelThe 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 | LAT-treated Community Model |
| care as usualAlso: Control groupControl group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual. | Other | Care as usual |
Primary outcome
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
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
13 secondary outcomes
Health economic evaluation
Time frame: 49 Weeks
Positive and Negative Syndrome Scale (PANSS)
Time frame: 49 Weeks
Hospitalization frequency
Time frame: 49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
Time frame: 49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
Time frame: 49 Weeks
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication
Time frame: 49 weeks
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
Time frame: 49 weeks
Family Burden Scale of Diseases (FBS)
Time frame: 49 Weeks
Personal and Social Performance Scale (PSP)
Time frame: 49 Weeks
Treatment Emergent Symptom Scale (TESS)
Time frame: 49 Weeks
Clinical laboratory examination
Time frame: 49 weeks
Electrocardiogram (ECG)
Time frame: 49 Weeks
Adverse events
Time frame: 49 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BaoLiang Zhong, Doctor contact
Yi Li, Doctor study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAT-treated Community Model and care as usual in people with Schizophrenia, run by Yi Li MD, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, Doctor ((+86)027-59372200, psylee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Violence Risk Assessment For Psychiatric Patients (time frame: 49 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.