NCT00862992已完成2 期
Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)
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
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Event and Adverse Drug Reaction
研究概览
简要总结
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting DSM-IV-TR criteria for schizophrenia
- •PANSS total score <= 120 during the observation period
- •Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
- •Patients whose consent is obtained from themselves in written form
排除标准
- •Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
- •History of drug or alcohol abuse
- •Concurrent Parkinson's disease
- •History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
- •Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
- •Current cataract during the observation period
- •History of shock or anaphylactoid symptoms to drugs
- •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
1
Experimental
干预措施: Cariprazine 3 mg (Drug)
2
Experimental
干预措施: Cariprazine 6 mg (Drug)
3
Experimental
干预措施: Cariprazine 12.5 mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Event and Adverse Drug Reaction
时间窗: Up to 7 weeks
次要结局
- Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14(Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.)
- Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14(Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14(Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.)
研究者
研究点 (1)
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