Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 主要终点
- Change in total PANSS score at endpoint
研究概览
简要总结
The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment.
Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol
- •Subject must sign a written informed consent.
排除标准
- •Have an uncontrolled, unstable, clinically significant medical condition.
研究组 & 干预措施
Arm 1
干预措施: asenapine (Drug)
Arm 2
干预措施: olanzapine (Drug)
结局指标
主要结局
Change in total PANSS score at endpoint
时间窗: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint
次要结局
- Changes in PANSS subscale scores and Marder factor scores(Every 24 weeks after baseline)
- Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)(Every 48 weeks after baseline)
- Resource utilization (as measured by frequency and length of hospital stay)(During the entire study period)
- Changes in CGI-S(Every 12 weeks after baseline)
- Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)(Every 24 weeks after baseline)
- Weight and vital signs(Every 4 weeks after baseline)
- Adverse Events(Continuously and up to 7 days after endpoint)
- Safety and tolerability: EPS (AIMS, BARS, SARS)(Every 24 weeks after baseline)
- Pregnancy Test(At endpoint)
- Blood Tests(Every 12 weeks after baseline)
- ECGs(Every 24 weeks after baseline)