Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
研究概览
简要总结
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
详细描述
The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
- •men and women aged 19 and under 60
- •a person who is being given an atypical antipsychotic.
- •Patients should be able to reasonably cooperate with the questionnaire to be used for the study
- •a person who fully understands the purpose of the study and signs the consent
- •stable outpatient before screening without changing the volume of antipsychotics for at least two weeks
排除标准
- •a person who has a serious and unstable physical condition either now or in the past
- •A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
- •a person suffering from severe drug allergies or complex and severe drug reactions
- •Patients who have taken clozapine in the last 60 days
- •subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment
研究组 & 干预措施
abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
干预措施: abilify maintena (Drug)
结局指标
主要结局
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
时间窗: 12weeks
PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
时间窗: 24weeks
PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
次要结局
- Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)(baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks)
- Efficacy Assessment by ERT(Emotional Recognition Test)(baseline, 24weeks)
- Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)(baseline, 12weeks, 24weeks)
- Efficacy Assessment by self rating scale(baseline, 12weeks, 24weeks)
- Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)(baseline, 12weeks, 24weeks)
- Safety Assessment by Simpson-Angus Scale(SAS)(baseline, 12weeks, 24weeks)
- Safety Assessment by Barnes Akathisia Rating Scale(BARS)(baseline, 12weeks, 24weeks)
- Safety Assessment by self report scale(baseline, 12weeks, 24weeks)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital