A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 主要终点
- Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
研究概览
简要总结
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
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
- •Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
- •No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
- •Caregiver required.
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
asenapine
干预措施: Asenapine (Drug)
olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
时间窗: Day 182
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.
次要结局
- Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score(Day 182)
- Change From Baseline in Body Weight(Day 182)