EUCTR2013-000426-62-NL进行中（未招募）不适用
A randomized, double blind, placebo-controlled crossover study to investigate the effects of a selective serotonergic reuptake inhibitor on resting state fMRI in healthy volunteers. - Pharmacological resting state fMRI with an SSRI.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Age 18-30 years, inclusive
- •Body-mass index (BMI) between 18 and 30 kg/m2.
- •Each subject is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written 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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Contra-indication to MRI scanning (pacemaker and defibrillator, intraorbital or intraocular metallic fragments, cochlear implants, one or more metal ear tubes, intracranial clips, a non-removable insulin pump, a non-removable neurostimulator, a mechanical cardiac valve, a hydrocephalus pump, ferromagnetic implants, intra-uterine device, permanent make-up, tattoos above the shoulders, pregnancy, operation in 6 weeks preceding the MRI, claustrophobia, inability to lie still for a period of 20 minutes in the MRI scanner, fear or problems during the RS-fMRI scan).
- •Relatives of study personnel directly involved with the conduct of the study, study investigators or sub-investigators.
- •Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator).
- •Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening (as judged by the investigator).
- •Positive test for hepatitis B, C or HIV.
- •Subjects using, on average, more than 4 units of alcohol per day, and unable to refrain from alcohol use during the study days.
- •Subjects smoking, on average, more than 5 cigarettes per day, and unable to refrain from smoking during the study days.
- •Subject is a habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at the time of the study and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) during study days.
- •Positive drug or alcohol test at screening and/or study day.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year.
- •Donation or loss of blood (> 500 mL) within 3 months prior to screening.
- •Inadequate venous accessibility as judged by the physician or nurse.
- •Use of benzodiazepine within 48 hours before a study day.
- •Pregnancy or breast feeding.
- •Any other condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject.
- •Use of medication in the 2 weeks prior to the first study day.
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