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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Modified Overt Aggression Scale (MOAS)
研究概览
简要总结
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.
详细描述
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treating physician as tolerance to the drug could usepaliperidone palmitate .Suggest previous antipsychotics could be withdrawn within 4 weeks after first paliperidone palmitate administration , but will follow doctors' clinical judgement.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor would not known the arm, and forbiden to ask and comminicate with patients about the intervention.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.-
排除标准
- •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.
结局指标
主要结局
Modified Overt Aggression Scale (MOAS)
时间窗: 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
Violence Risk Assessment For Psychiatric Patients
时间窗: 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
次要结局
- Health economic evaluation(49 Weeks)
- WHO Quality of Life-BREF (WHOQOL-BREF) of patients(49 Weeks)
- WHO Quality of Life-BREF (WHOQOL-BREF) of caregiver(49 Weeks)
- Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication(49 weeks)
- Family Burden Scale of Diseases (FBS)(49 Weeks)
- Personal and Social Performance Scale (PSP)(49 Weeks)
- Positive and Negative Syndrome Scale (PANSS)(49 Weeks)
- Clinical laboratory examination(49 weeks)
- Electrocardiogram (ECG)(49 Weeks)
- Hospitalization frequency(49 Weeks)
- Treatment Emergent Symptom Scale (TESS)(49 Weeks)
- Visual Analogue Scale-100 (VAS 100) of patients treatment satisfication(49 weeks)
- Adverse events(49 weeks)
研究者
Yi Li MD, PhD
Research clinician
Huazhong University of Science and Technology