NCT01625897已完成2 期
A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly 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
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient before the initiation of any study-specific procedures
- •Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- •Patients who meet at least one of the following:
- •current diagnosis of schizophrenia of chronic phase
- •between 65 and 74 years of age
- •Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
排除标准
- •Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- •The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
MP-214 1.5-9mg
Experimental
干预措施: MP-214 (Drug)
Risperidone 2-12mg
Active Comparator
干预措施: Risperidone (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 60 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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