Clinical trial NCT03434210: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
violence risk
long-acting antipsychotics
community-based
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Violence Risk Assessment For Psychiatric Patients
timeFrame: 49 Weeks
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: 49 Weeks
Secondary outcomes:
measure: Health economic evaluation
timeFrame: 49 Weeks
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 49 Weeks
measure: Hospitalization frequency
timeFrame: 49 Weeks
measure: WHO Quality of Life-BREF (WHOQOL-BREF) of patients
timeFrame: 49 Weeks
measure: WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver
timeFrame: 49 Weeks
measure: Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication
timeFrame: 49 weeks
measure: Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
timeFrame: 49 weeks
measure: Family Burden Scale of Diseases (FBS)
timeFrame: 49 Weeks
measure: Personal and Social Performance Scale (PSP)
timeFrame: 49 Weeks
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: 49 Weeks
measure: Clinical laboratory examination
timeFrame: 49 weeks
measure: Electrocardiogram (ECG)
timeFrame: 49 Weeks
measure: Adverse events
timeFrame: 49 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan mental health center
state: Wuhan
Study officials:
affiliation: Wuhan Union Hospital, China
name: Yi Li, Doctor
role: STUDY_DIRECTOR
References: