An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
研究概览
简要总结
The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
详细描述
This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be administered. For all participants enrolled (Group 1 to 3) the study will consist of an eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which are separated by overnight sleep. In addition, a session will be performed on Day 7. Completion of the cognitive test batteries can occur at any time during the day provided that the completion time is comparable on all test days. For each participant, the maximal study duration will not exceed 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 (patients with schizophrenia):
- •Be a man or woman between 18 and 55 years of age, inclusive
- •Has a known history of schizophrenia of at least 12 months by the referring psychiatrist
- •Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior to screening
- •Medically stable on the basis of clinical judgment by the investigator
- •Group 2 (young healthy volunteers): be a healthy man or woman between 18 and 55 years of age, inclusive
- •Group 3 (elderly healthy volunteers): be a healthy man or woman between 65 and 85 years of age, inclusive
- •All participants (Group 1 to 3) must be capable of completing the cognitive test battery
排除标准
- •Receives treatment with benzodiazepines, tricyclic antidepressant or anticholinergics
- •Has a positive urine screen for drugs of abuse or alcohol breath test
- •Has a recent history (within previous 6 months) of alcohol or drug abuse
- •Has psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the participant to comply with the study requirements
- •Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the participant or the study or prevent the participant from meeting or performing study requirements
- •Group 1 only: a diagnosis of substance dependence within 3 months prior to screening evaluation (patient with a positive drug screen at screening may be included provided use does not lead to a diagnosis of substance dependence and patient consents to abstain from illegal drugs at any time during the study)
研究组 & 干预措施
Group 1: Patients with schizophrenia
干预措施: Cognitive Test Battery 2 (Behavioral)
Group 2: Young healthy volunteers
干预措施: Cognitive Test Battery 1 (Behavioral)
Group 2: Young healthy volunteers
干预措施: Cognitive Test Battery 2 (Behavioral)
Group 3: Elderly healthy volunteers
干预措施: Cognitive Test Battery 1 (Behavioral)
Group 3: Elderly healthy volunteers
干预措施: Cognitive Test Battery 2 (Behavioral)
Group 1: Patients with schizophrenia
干预措施: Cognitive Test Battery 1 (Behavioral)
结局指标
主要结局
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
时间窗: 7 days
The cognitive data will be summarized and summary statistics calculated (including mean, standard deviation, median, minimum, and maximum values) for each experiment and participants group.
次要结局
- Incidence of Adverse Events(7 days)