The Effects of Ondansetron on Brain Function

NCT02460341 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GCO 14-1794
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Function; Healthy Adults

Keywords

fMRI; Brain function; Sensory processing

Outcome Measures

Primary Outcomes (2)

• BOLD signal in the insula and somatosensory cortex measured by fMRI

  On Day1, Functional magnetic resonance imaging (fMRI) will be done 90 minutes after drug or placebo ingestion to measure the blood oxygen level dependent (BOLD) signal in insula and somatosensory cortex.

  Day 1

• BOLD signal in the insula and somatosensory cortex measured by fMRI

  At week 1, fMRI will be done 90 minutes after drug or placebo ingestion to measure the BOLD signal in insula and somatosensory cortex.

  1 week

Secondary Outcomes (2)

• BOLD signal in the whole brain measured by fMRI

  Day 1

• BOLD signal in the whole brain measured by fMRI

  1 week

Study Arms (3)

ondansetron-8

EXPERIMENTAL

Single dose of 8 mg ondansetron (crossover with single dose of placebo)

Drug: ondansetron; Drug: placebo

ondansetron-16

EXPERIMENTAL

Single dose of 16 mg ondansetron (crossover with single dose of placebo)

Drug: ondansetron; Drug: placebo

ondansetron-24

EXPERIMENTAL

Single dose of 24 mg ondansetron (crossover with single dose of placebo)

Drug: ondansetron; Drug: placebo

Interventions

ondansetron DRUG

Ondansetron 8mg, 16mg, 24mg

Also known as: Zofran

ondansetron-16; ondansetron-24; ondansetron-8

placebo DRUG

placebo pill

ondansetron-16; ondansetron-24; ondansetron-8

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Emily Stern, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: August 1, 2015
• Primary Completion: February 3, 2017
• Study Completion: February 3, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)