EUCTR2016-004970-16-AT进行中（未招募）1 期
Imaging the functional and molecular impact of poly-unsaturated fatty acids on dopamine-dependent cognitive functions: a combined [11C]-(+)-PHNO PET/MRI study at different stages of cognitive impairment - Fatty acids in cognition
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All subjects
- •age 18-65
- •good general health
- •absence of relevant abnormalities in laboratory screening, ECG or vital signs
- •no regular use of drugs of abuse or alcohol based on history and urine drug screen.
- •Healthy subjects
- •Absence of psychiatric disorders according to M.I.N.I.
- •ARMS subjects
- •CAARMS above ARMS threshold
- •Patients with schizophrenia
- •diagnosis of SCZ or other non-affective psychotic disorder according to DSM-5
- •minimum Positive and Negative Syndrome Scale (PANSS) total score of 55 (> 3 on at least two or >4 on one psychosis item
- •ability to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All subjects
- •severe or unstable medical or neurologic disorders or clinically significant abnormality on screening laboratory studies
- •clinically relevant abnormalities in the electro-cardiogram (ECG)
- •history of myocardial infarction or angina pectoris, arterial hypertension or paroxysmal hypertensive states
- •established diagnosis of advanced arteriosclerosis or hyperthyroidism
- •current substance use disorder (except nicotine)
- •lifetime use of stimulants exceeding 5 or more exposures
- •pregnancy or breast feeding
- •known hypersensitivity to sympathomimetics
- •history of severe head trauma
- •positive urine drug screen
- •presence of MRI exclusion criteria
- •if participation in this study would exceed annual radiation dose limits (30mSv)
- •known allergy to any ingredients of the PUFA or placebo capsules
- •Patients with schizophrenia
- •previous oral antipsychotic treatment for more than 2 weeks, or antipsychotics within two weeks prior to PET scan; previous treatment with antipsychotic depot preparation.
- •ARMS subjects
- •psychotic disorder according to DSM-5 (CAARMS above psychosis threshold)
研究者
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