The Effects of Ondansetron on Brain Function

Completed · Phase 1 · Has a placebo group

Conditions studied: Brain Function, Healthy Adults

In brief

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.

Key facts

Study ID

NCT02460341

Run by

Icahn School of Medicine at Mount Sinai

People needed

54

Starts

2015-08-01

Expected to finish

2017-02-03

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects must be medically healthy, between 18 and 60 years of age, and fluent (speaking and writing) in English

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.