NCT01625000已完成2 期
A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With 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
- 512
- 试验地点
- 3
- 主要终点
- Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of 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
- 20 Years 至 64 Years（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 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 3mg
Experimental
干预措施: MP-214 3mg (Drug)
MP-214 6mg
Experimental
干预措施: MP-214 6mg (Drug)
MP-214 9mg
Experimental
干预措施: MP-214 9mg (Drug)
Risperidone 4mg
Active Comparator
干预措施: Risperidone 4mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
时间窗: Baseline and Week 6
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
次要结局
- Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6(Baseline and Week 6)
研究者
研究点 (3)
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