A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 593
- 试验地点
- 2
- 主要终点
- Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
详细描述
Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.
Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia
- •PANSS-T of at least 70 at screening and baseline
排除标准
- •Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
- •DSM-IV diagnosis of psychiatric disorder other than schizophrenia
研究组 & 干预措施
Iloperidone
Oral iloperidone
干预措施: Iloperidone (Drug)
Ziprasidone
Oral ziprasidone
干预措施: Ziprasidone (Drug)
Placebo
Oral placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
时间窗: 4 weeks
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
次要结局
未报告次要终点