NCT01655680已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers
AbbVie (prior sponsor, Abbott)61 个研究点 分布在 2 个国家目标入组 432 人开始时间: 2012年5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
- 432
- 试验地点
- 61
- 主要终点
- Cognition: MCCB (MATRICS Consensus Cognitive Battery)
研究概览
简要总结
This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
详细描述
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
- •Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications: lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (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 contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.
排除标准
- •In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
- •Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
- •Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
- •Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
- •Has any risk factors for Torsades de Pointes (TdP)
研究组 & 干预措施
ABT-126 Low Dose
Experimental
ABT-126 Low Dose
干预措施: ABT-126 (Drug)
ABT-126 Middle Dose
Experimental
ABT-126 Middle Dose
干预措施: ABT-126 (Drug)
ABT-126 High Dose
Experimental
ABT-126 High Dose
干预措施: ABT-126 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cognition: MCCB (MATRICS Consensus Cognitive Battery)
时间窗: Change from baseline to week 24
Rater based interview
次要结局
- Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)(Measurements from screening period up through week 24)
- Symptom Severity: PANSS (Positive and Negative Symptom Scale)(Measurements from screening period up through week 24)
- Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)(Measurements from screening period up through week 24)
研究者
研究点 (61)
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