NCT01077700已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
AbbVie (prior sponsor, Abbott)24 个研究点 分布在 1 个国家目标入组 214 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
- 214
- 试验地点
- 24
- 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-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 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
- •Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview.
- •Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks.
- •Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit.
- •Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit.
- •Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements.
排除标准
- •Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode.
- •Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit.
- •Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit.
- •Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.
- •Has significant suicidal ideation at Initial Screening Visit.
- •Has had a suicide attempt within 1 year prior to the Day -1 Visit.
- •Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery (MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6 months prior to Initial Screening Visit.
- •Is currently enrolled in any form of cognitive remediation training.
研究组 & 干预措施
ABT-288 Dose 1
Experimental
low dose of ABT-288
干预措施: ABT-288 Low Dose (Drug)
ABT-288 Dose 2
Experimental
high dose of ABT-288
干预措施: ABT-288 High Dose (Drug)
Sugar Pill
Placebo Comparator
inactive substance
干预措施: Placebo (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
研究点 (24)
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