A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Add-On Therapy, 2-Period Cross-Over Clinical Trial to Evaluate the Safety and Efficacy of MK5757 for the Treatment of Cognitive Impairment in Men With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
研究概览
简要总结
This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is male between 21 and 55 years of age
- •Duration of the illness must be longer than 1 year
- •Patient's current antipsychotic medication regimen must be stable
- •Patient is negative for selected drugs of abuse at Screening
- •Must be in a stable living arrangement for at least 3 months prior to screening (not a homeless shelter)
排除标准
- •Patient has mental retardation
- •Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
- •Has suicidal attempts or ideation within the last 12 months
- •Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study
研究组 & 干预措施
1
MK5757
干预措施: MK5757 (Drug)
结局指标
主要结局
Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
时间窗: Baseline and Week 2
The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.
次要结局
- Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score(Baseline and week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score(Baseline and Week 2)