Translational Neuroscience Optimization of GlyT1 Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
研究概览
简要总结
This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this study is to test the efficacy of treatment with one of two does of a glycine transporter inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function. Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I) and placebo twice daily in addition to their antipsychotic medication for 2 treatment periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout period lasting approximately 3 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 21 to 65 years of age (inclusive).
- •Diagnosis of Schizophrenia or Schizoaffective Disorder
- •Able to provide written informed consent.
- •Only CYP2D6 extensive metabolizers.
排除标准
- •No ongoing acute medical issues
- •Clinically significant ECG abnormality
- •Blood donation within eight weeks of the start of the study
- •Current treatment with Clozapine
研究组 & 干预措施
PF-03463275 Active Dose #1
Active dose between 40mg
干预措施: PF-03463275 (Drug)
PF-03463275 Active Dose #2
Active dose between 60mg
干预措施: PF-03463275 (Drug)
Placebo
Placebo- no active dose of PF-03463275.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
时间窗: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.
To test the efficacy of PF-03463275 on cognitive test performance specifically, the MCCB composite score was used. The MCCB consists of 10 tests and provides standard scores and percentiles for each of seven cognitive domains and an overall composite score. Domains assessed include: speed of processing, attention/vigilance, working memory (verbal and visual), verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite score is presented as a T-score. The range of T-scores is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.
次要结局
- Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275(Change from Baseline at approximately 1 week)