Treatment of Cognitive Disability in Schizophrenia With a GABA-A Alpha2/3 Receptor Agonist
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- N-back Task - Reaction Time
研究概览
简要总结
The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.
详细描述
The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants
- •Between the ages of 18 and 50
- •Meet diagnostic criteria for schizophrenia or schizoaffective disorder
- •Are clinically stable for a minimum of 3 months on current dose of medication
- •Are unemployed (i.e., work less than 20 hours per week at competitive employment)
排除标准
- •Psychoactive substance dependence within the past 6 months or substance abuse within the past month
- •History of head trauma or other neurological disorder
- •Medical illness or medications, such as benzodiazepine treatment or HIV medications, that may be affected by study participation (the study doctor will discuss this with potential subjects)
- •Mental retardation
- •Seizure disorder
- •History of a heart attack, arrhythmia, or other heart disease
研究组 & 干预措施
Merck L-830982
干预措施: Merck L-830982 (Drug)
Sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
N-back Task - Reaction Time
时间窗: Week 4
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
N-back Task - Error Rate
时间窗: Week 4
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
AX Continuous Performance Test Task D-prime
时间窗: Week 4
For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.
Preparing to Overcome Prepotency (POP) Task - Reaction Time
时间窗: Week 4
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
Preparing to Overcome Prepotency Task - Error Rate
时间窗: Week 4
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
次要结局
- Brief Psychiatric Rating Scale Total Score(Week 4)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score(Week 4)
- Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex(Week 4)