The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale(PANSS)
研究概览
简要总结
This is a 49 weeks prospective, non-interventional cohort study. To observe the effect of long-acting injection antipsychotic(LAI), paliperidone palmitate on prevention of recurrence and symptom control in schizophrenia patients with violence risk. This study can be extended according to the implementation of the project and extended follow-up time.
详细描述
This is a 49 weeks prospective, observational cohort study. Wuhan initiated a project to improve the LAI treatment in schizophrenia patient with violence risk. This observational study will build the cohort of schizophrenia patient with violence risk and treated with LAI paliperidone palmitate. The effect of long-acting antipsychotic, paliperidone palmitate, will be observed on prevention of recurrence and symptom control in these patients. safety information and laboratory tests result will also be collected. This study can be extended according to the implementation of the project and extended follow-up time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Positive and Negative Syndrome Scale(PANSS)
时间窗: 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).
次要结局
- Hospitalization frequency(49 Weeks)
- Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction(49 Weeks)
- Violence Risk Assessment For Psychiatric Patients(49 Weeks)
- Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication(49 Weeks)
- Treatment Emergent Symptom Scale (TESS)(49 Weeks)
- Electrocardiogram (ECG)(49 Weeks)
- Adverse events(49 Weeks)
- Modified Overt Aggression Scale (MOAS)(49 Weeks)
- Renal function tests(49 weeks)
- WHO Quality of Life-BREF (WHOQOL-BREF) of patients(49 Weeks)
- Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction(49 Weeks)
- Personal and Social Performance Scale (PSP)(49 Weeks)
- Calgary Depression Scale of Schizophrenia(CDSS)(49 weeks)
- Liver function tests(49 weeks)
- RBANS(49 weeks)
- Interpersonal Reactivity Index(IRI)(49 weeks)
- Blood glucose tests(49 weeks)
- Blood lipid tests(49 weeks)
- STROOP test(49 weeks)
- Facial Emotion Recognition scale(49 weeks)
- Toronto Alexithymia Scale(TAS)(49 weeks)
研究者
Yi Li MD, PhD
Professor
Huazhong University of Science and Technology