NCT01398189Unknown不适用
Validation of Molecular Imaging Technologies for Early Clinical Trials
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- pharmacodynamics of F-18 artanserin
研究概览
简要总结
To examine the feasibility of molecular imaging markers in clinical psychopharmacology
详细描述
Clinical evaluation of patients with psychiatric disorders is mainly dependent on patients' reports and clinicians' observations. In order to develop objective and quantifiable measures of psychopathology, molecular imaging techniques will be used in patients receiving clozapine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overtly healthy males as determined by medical history and physical examination
- •Age from 19 to 45 years
- •Weight ≥ 45 kg and within ± 20% of IBW
- •Clinical laboratory test results within normal reference range for the National Cancer Center, Hospital or results with minor deviations which are judged to be not clinically significant by the investigator
- •Normal blood pressure and heart rate (supine and standing) as determined by the investigator
- •Are reliable and willing to make themselves available for the duration of the study, and who will abide by the study restrictions
- •Have given written informed consent
排除标准
- •Evidence of significant active hematologic disease
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- •An episode of febrile disease or infectious disease within the past 2 weeks
- •Evidence of significant active neuropsychiatric disease
- •Regular use of drugs or abuse
- •History of drug hypersensitivity or clinically significant allergic reactions of any origin
- •Participation in a study involving administration of an investigational compound within the past 30 days
- •Use of any current medication
- •Smoking history for recent 3 months
研究组 & 干预措施
clozapine
Experimental
patients with refractory schizophrenia or schizoaffective disorder
干预措施: clozapine (Drug)
结局指标
主要结局
pharmacodynamics of F-18 artanserin
时间窗: 84 days
PET imaging with F-18 altanserin infusion
次要结局
- serum level of clozapine and metabolites(84 days)
研究者
Jae Seung Chang
Clinical Assistant Professor
Seoul National University Bundang Hospital
研究点 (1)
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