A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,225
- 主要终点
- Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
研究概览
简要总结
The primary features of schizophrenia and schizoaffective disorder are characterized by 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 or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
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. Subject must sign a written informed consent.
排除标准
- •Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
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 (52-week double-blind or last assessment after baseline) from baseline
时间窗: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
次要结局
- Resource utilization (as measured by frequency and length of hospital stay)(During the study period)
- Changes in PANSS subscale scores and Marder factor scores(At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint)
- Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)(At endpoint)
- Population kinetics(Plasma samples at weeks 2 and 6 in comparison with baseline)
- Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)(During the study period)
- Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)(At weeks 8, 20, 28, 36, 44 and endpoint)
- Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)(At weeks 6, 28 and endpoint)
- Safety and tolerability: EPS (AIMS, BARS, SARS)(At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint)
- Weight and vital signs(at all assessment time points from baseline)
- Changes in CGI-S(At each assessment time point from baseline)
- Adverse Events(continuously and up to 7 days after endpoint)
- Pregnancy Test(At endpoint)
- Blood Test(At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint)
- ECGs(Weeks 3, 6, 24, and endpoint)