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Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

NCT03239210 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-05-03

Study results available
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Summary

This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4 weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2 weeks into the trial for symptom assessments. The investigators hypothesize that after 4 weeks there will be greater reduction from baseline in sensory symptoms and the activation of the insula and sensorimotor cortex compared for ondansetron as compared to placebo.

Conditions

  • Obsessive-Compulsive Disorder
  • Tic Disorders
  • Tourette Syndrome

Interventions

DRUG

Ondansetron

5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting

DRUG

Placebo

placebo equivalent

Sponsors & Collaborators

Principal Investigators

  • Emily Stern, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239210 on ClinicalTrials.gov