Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (e-CAeSAR)
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach
This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive remediation treatment versus a computer-based control.
The investigators proposed that a computerized cognitive remediation program based upon the principles of brain plasticity may improve information processing and thus drive clinically significant improvements in cognitive and functional performance in individuals with schizophrenia.
研究概览
详细说明
The symptoms of schizophrenia fall into three main categories: positive symptoms, negative symptoms, and cognitive symptoms. Each category represents distinct functional challenges and impedes patient productivity and overall quality of life.
Cognitive symptoms are pervasive and result in deficits in executive functioning (the ability to understand information and use it to make decisions), attention (the ability to identify, select, and focus on relevant sensory events), and working memory (the ability to hold information in memory and then guide actions from it). These symptoms impair patients' abilities to successfully perform everyday activities, including independent living, employment, and social relationships, and in addition can cause great emotional distress.
Cognitive impairment in schizophrenia has now received substantial academic study, with over 24,000 research papers published in the field since 1990. This enormous body of work has shown that cognitive impairment is likely to be present in virtually all patients with schizophrenia, regardless of their severity of illness or treatment status. People with schizophrenia typically perform 1-2 standard deviations below the mean of age-matched controls (indicating substantial impairment) across the domains of speed of information processing, attention, working memory, verbal and visual learning, reasoning and social cognition.
While cognitive impairment in schizophrenia was originally assumed to be secondary to positive or negative symptoms of the disorder, or related to the use of anti-psychotic medications, recent research has conclusively shown that neither of these past assumptions is true. For example, the landmark Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial involving 1,493 participants demonstrated that negative symptoms are only mildly correlated with cognitive function, and that positive symptoms are completely uncorrelated with cognitive function. Furthermore, research has shown that cognitive impairment is evident in people with schizophrenia before they are medicated, prior to diagnosis, and in first-degree relatives of people diagnosed with schizophrenia; indicating that medication is not the cause of cognitive impairment. In aggregate, these data have established the well-accepted current viewpoint that cognitive dysfunction is a core primary symptom and deficit in schizophrenia.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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Palo Alto、California、美国、94304
- Palo Alto Veteran's Affairs Medical Center
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San Francisco、California、美国、94108
- Posit Science Corporation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years of older with confirmed diagnosis of Schizophrenia
- Adequate decisional and reading capacity
- Clinical stable
- Moderate or less severity on Positive and Negative Symptoms Scale
- English speaker
- Capable of completing clinical and cognitive assessment battery
- Lack of visual, auditory or motor capacity to participate in the study
- Minimal level of extrapyramidal symptoms
- Minimal level of depressive symptoms
Exclusion Criteria:
- Failure to meet suicidality rating criteria
- Prescribed greater than 2 anti-psychotics
- Significant alcohol and illicit drug use
- History of mental retardation or pervasive developmental disorder or other neurological disorder
- Prior specified computer-based cognitive remediation training
- Participation in a concurrent study that could affect the outcome of this one
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
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其他名称:
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有源比较器:Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
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Computer games
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
大体时间:6 Months
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Each outcome score (MCCB composite score and UPSA-2 total score) will be analyzed separately.
The treatment efficacy will be established if and only if both tests on MCCB and UPSA-2 are significant at two-sided alpha level of 0.05.
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6 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Demonstration of equivalency in safety effects reported between treatment groups.
大体时间:6 Months
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Positive and Negative Symptom Scale (PANSS) positive symptom scale, negative symptom scale and total scale will be assessed at study mid-point and study end.
Adverse effects by treatment group will also be assessed at study mid-point and study end.
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6 Months
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合作者和调查者
调查人员
- 首席研究员:Henry W. Mahncke, PhD、Posit Science Corporation
- 首席研究员:Richard Keefe, PhD、Schizophrenia Trials Network
- 首席研究员:Scott Stroup, MD, MPH、Schizophrenia Trials Network
- 研究主任:Cate Stasio、Posit Science Corporation
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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