A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the 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
- •Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the 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
- •Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
- •Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit
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 or clozapine 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 the past 5 years
- •Patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening
研究组 & 干预措施
MK0249
干预措施: MK0249 (Drug)
结局指标
主要结局
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
时间窗: Baseline and 4 weeks of treatment
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
次要结局
- Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score(Baseline and 4 weeks of treatment)
- Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score(Baseline and 4 weeks of treatment)
- Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score(Baseline and 4 weeks of treatment)