The Effects of Ondansetron on Brain Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- BOLD signal in the insula and somatosensory cortex measured by fMRI
研究概览
简要总结
This project investigates the effects of a single dose of ondansetron on brain function in healthy adults. The investigators hypothesize that there will be a dose-dependent reduction in activation of the insula and somatosensory brain regions associated with the use of ondansetron.
详细描述
Objectives:
The overall objective of this study is to examine the effects of single doses of 8 mg, 16 mg, and 24 mg ondansetron as compared to placebo on neural mechanisms of cognition and perception in healthy individuals.
Background:
Many psychiatric disorders are associated with altered sensory experiences arising from within the body. Examples include increased experience of sensations or urges in muscles, skins, joints or visceral organs in tic disorders, OCD patients with symptoms of "not just right experiences" or disgust sensitivity, and impulse control disorders (ICDs) such as trichotillomania or skin-picking. In OCD, sensory phenomena occur in approximately half of patients, are associated with earlier age of onset, and may be harder to treat with classic cognitive-behavioral approaches to OCD. Of interest, sensory phenomena in OCD are associated with Tourette's syndrome and respond to pharmacological treatments primarily used for tics. As such, abnormal sensory processing may be a basic mechanism that links various psychiatric disorders.
The process of attending to body sensations is referred to as interoception, and broadly includes the detection of, or attention to, experiences arising from the viscera and soma. Research has revealed a cortical interoceptive circuit involving insula, anterior cingulate cortex (ACC), and somatomotor cortex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must be medically healthy, between 18 and 60 years of age, and fluent (speaking and writing) in English
排除标准
- •Present or previous diagnosis of any psychiatric disorder or major developmental disorder (autism/Asperger's disorder, pervasive developmental disorder), based on psychiatric evaluation using the Mini International Neuropsychiatric Interview (M.I.N.I.) or Structured Clinical Interview for DSM disorders (SCID)
- •Any disability or health problem that prevents them from completing study procedures (e.g. color blindness, severe carpal tunnel syndrome, etc.)
- •History of organic mental syndromes, head trauma, migraines, seizures, other CNS neurological disease, recent use of illegal drugs or current substance dependence, or significant medical illness other than that listed above (by self-report)
- •Pregnant or nursing women
- •Subjects with a medical condition or other predisposition that increases the risk of adverse effects when taking ondansetron. These include individuals with drug allergies or known hypersensitivity to ondansetron (or other 5-HT3 antagonists), heart disease, congestive heart failure, heart rhythm disorder, congenital long QT syndrome, electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia) or hepatic impairment
- •Subjects who report taking apomorphine will be excluded
- •Subjects with abnormal EKG will either be excluded from participation, or referred to a cardiologist for further assessment of eligibility
- •Subjects with abnormal liver function or electrolytes (as determined by blood test) will be excluded from participation if a study team physician determines it is unsafe for them to participate
- •Cross-reactivity with other 5-HT3 antagonists has been reported, so any individual taking a 5-HT3 antagonist will be excluded
研究组 & 干预措施
ondansetron-24
Single dose of 24 mg ondansetron (crossover with single dose of placebo)
干预措施: placebo (Drug)
ondansetron-8
Single dose of 8 mg ondansetron (crossover with single dose of placebo)
干预措施: ondansetron (Drug)
ondansetron-8
Single dose of 8 mg ondansetron (crossover with single dose of placebo)
干预措施: placebo (Drug)
ondansetron-16
Single dose of 16 mg ondansetron (crossover with single dose of placebo)
干预措施: ondansetron (Drug)
ondansetron-16
Single dose of 16 mg ondansetron (crossover with single dose of placebo)
干预措施: placebo (Drug)
ondansetron-24
Single dose of 24 mg ondansetron (crossover with single dose of placebo)
干预措施: ondansetron (Drug)
结局指标
主要结局
BOLD signal in the insula and somatosensory cortex measured by fMRI
时间窗: 1 week
At week 1, fMRI will be done 90 minutes after drug or placebo ingestion to measure the BOLD signal in insula and somatosensory cortex.
次要结局
- BOLD signal in the whole brain measured by fMRI(1 week)
研究者
Emily Stern
Assistant Professor
Icahn School of Medicine at Mount Sinai