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临床试验/NCT01095562
NCT01095562已完成2 期

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)

AbbVie (prior sponsor, Abbott)23 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Sugar Pill

Placebo Comparator

干预措施: Placebo (Drug)

ABT-126 Dose 1

Experimental

干预措施: ABT-126 (Drug)

ABT-126 Dose 2

Experimental

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)

研究者

发起方
AbbVie (prior sponsor, Abbott)
申办方类型
Industry
责任方
Sponsor

研究点 (23)

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