Aripiprazole in Adolescents With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Schizophrenia 1
排除标准
- •Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder
研究组 & 干预措施
Aripiprazole 10 mg/day Group
Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
干预措施: Aripiprazole tablet, 10 mg (Drug)
Aripiprazole 30 mg/day Group
Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
干预措施: Aripiprazole tablet, 30 mg (Drug)
Placebo Group
Participants were given a single pill administered once daily
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline and Day 42
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
次要结局
- Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score(Baseline and Day 42)
- Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score(Baseline and Day 42)
- Change in Clinical Global Impression (CGI) Severity Score(Baseline and Day 42)
- Clinical Global Impression (CGI) Improvement Score(Baseline and Day 42)
- Change in Children's Global Assessment Scale (CGAS) Score(Baseline and Day 42)