NCT01926873已完成不适用
MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Cognitive status of volunteers
研究概览
简要总结
This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18 to 65 years of age, inclusive
- •Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
- •A body mass index between 18 to 30 kg/m2 inclusive
- •Able to participate and willing to give written informed consent and to comply with the study restrictions
- •At least second generation resident in the country of origin
排除标准
- •Current or past history of a psychiatric disorder
- •Family history of psychiatric disorders
- •Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
- •Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
- •Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
- •Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
- •Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
- •Resting Pulse Rate greater than 100 or less than 45 beats per minute
- •Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
- •Participation in an investigational drug study within 1 month prior to baseline
结局指标
主要结局
Cognitive status of volunteers
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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