A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- BACS Composite RAW Score
研究概览
简要总结
The purpose of this study is to evaluate the effects of the amino acid supplement N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.
详细描述
Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve performance of patients with schizophrenia on a battery of cognitive tasks utilized to test working memory and other cognitive domains, versus placebo. This pilot study will utilize a randomized, double blind, placebo controlled, crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be between 18-60
- •Meet Diagnostic and Statistical Manual-IV (DSM) criteria for schizophrenia
- •Be on a stable dose of antipsychotic medication for at least 1 month
- •Be deemed clinically stable for 3 months by the regular clinical staff
排除标准
- •Current substance or alcohol abuse
- •Pregnancy
- •Clozapine treatment
- •Known sensitivity to sulphur containing compounds
- •Previous diagnosis of mental retardation
- •Nitroglycerin use
- •Asthma diagnosis, verified and treated by a primary care doctor
- •Use of any other medication that may interact with the study medication
研究组 & 干预措施
Group A: Intervention/Placebo
Group A first receives the commercially available sustained release form of N-acetylcysteine, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
干预措施: N-Acetylcysteine (Dietary Supplement)
Group B: Placebo/Intervention
Group B first receives the placebo and then receives a commercially available sustained release form of N-Acetylcysteine. In each arm, the capsules are both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
干预措施: Placebo (Drug)
结局指标
主要结局
BACS Composite RAW Score
时间窗: Follow Up 2nd Leg of Crossover (5 Days)
The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.
次要结局
- Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.(Follow Up 2nd Leg of Crossover (5 Days))
- Brief Visuospatial Memory Test (BVMT) RAW SCORE.(Follow Up 2nd Leg of Crossover (5 Days))
- Brief Psychiatric Rating Scale (BPRS)Total Score(Change from PreScreening at End of Trial)