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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 主要终点
- Violence Risk Assessment For Severe Psychiatric Patients
研究概览
简要总结
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.
详细描述
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.
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
- None
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) 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.
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.
研究组 & 干预措施
paliperidone palmitate group
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.
干预措施: paliperidone palmitate (Drug)
control group
The subjects in control group will be applied with oral antipsychotics or other conventional medication.
干预措施: control group (Drug)
结局指标
主要结局
Violence Risk Assessment For Severe Psychiatric Patients
时间窗: 1 year
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
次要结局
- Adverse events(1 year)
- Modified Overt Aggression Scale (MOAS)(1 year)
- Health economic evaluation(1 year)
- Positive and Negative Syndrome Scale (PANSS)(1 year)
- Hospitalization frequency(1 year)
- WHO Quality of Life-BREF (WHOQOL-BREF)(1 year)
- Visual Analogue Scale-100 (VAS 100)(1 year)
- Family Burden Scale of Diseases (FBS)(1 year)
- Personal and Social Performance Scale (PSP)(1 year)
- Treatment Emergent Symptom Scale (TESS)(1 year)
- Vital signs(1 year)
- Clinical laboratory examination(1 year)
- Electrocardiogram (ECG)(1 year)
研究者
Maosheng Fang
Research clinician
Huazhong University of Science and Technology