A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 23
- 主要终点
- Cognition: MCCB
研究概览
简要总结
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
详细描述
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-126 compared to placebo can improve cognition and what side effects ABT-126 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below: • MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery • UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2 • CANTAB: Cambridge Neuropsychological Test Automated Battery • PANSS: Positive and Negative Syndrome Scale • NSA-16: Negative Symptom Assessment-16 • CGI-S: Clinical Global Impression - Severity
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sugar Pill
干预措施: Placebo (Drug)
ABT-126 Dose 1
干预措施: ABT-126 (Drug)
ABT-126 Dose 2
干预措施: ABT-126 (Drug)
结局指标
主要结局
Cognition: MCCB
时间窗: Measurements from screening period through 12-week treatment period
次要结局
- Functioning: UPSA-2(Measurements from screening period through 12-week treatment period)
- Symptom Severity: PANSS, NSA-16, CGI-S(Measurements from screening period through 12-week treatment period)
- Cognition: CANTAB(Measurements from screening period through 12-week treatment period)
