NCT00482430已完成2 期
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment 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
- 50
- 主要终点
- Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
- •Patient has a 6th grade reading level or better and has completed at least 6 years of formal education
- •Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study
- •Patient has had a stable living arrangement for at least 3 months prior to study start
- •Patient is in general good health based on screening assessments
排除标准
- •Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
- •Patient has a history of head trauma with loss of consciousness greater than 15 minutes
- •Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening
- •Patient has had ECT treatment within 6 months of screening
- •Patient requires treatment with antihistamines or certain other medications listed in the protocol
- •Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years
- •Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening
研究组 & 干预措施
1
Other
MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
干预措施: MK0557 (Drug)
2
Other
MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
干预措施: MK0557 (Drug)
结局指标
主要结局
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
时间窗: at 4 weeks of treatment
次要结局
- Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory(at 4 weeks of treatment)
研究者
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