A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy 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
- 481
- 主要终点
- Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale
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, have 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
Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale
时间窗: Change from baseline at 6-months
次要结局
- Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale(Change from baseline at 6-months)
- Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS)(Change from baseline at 6-months)
- Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)(Change from baseline at 6-months)
- Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I)(Change from baseline at 6-months)