Status:
COMPLETED
Effects of Ondansetron in Obsessive-compulsive and Tic Disorders
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Obsessive-Compulsive Disorder
Tic Disorders
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 (T...
Detailed Description
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 visce...
Eligibility Criteria
Inclusion
- Patients must be medically healthy, between 18 and 60 years of age
- Fluent (speaking and writing) in English
- Patients must have a current diagnosis of obsessive-compulsive disorder (OCD) or tic disorder (OCD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria with moderate or greater disorder severity and moderate or greater severity of sensory phenomena
- Patients must be unmedicated or taking antidepressants, stable for at least 6 weeks
Exclusion
- Present or previous diagnosis of any psychosis, bipolar disorder, or major developmental disorder (autism/Asperger's disorder, pervasive developmental disorder). Present diagnosis of alcohol or substance use disorder (moderate or severe) will also be exclusionary.
- 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 central nervous system (CNS) neurological disease, or significant medical illness other than that listed above.
- Pregnant or nursing women will be excluded.
- Subjects with a medical condition or other predisposition that increases the risk of adverse effects when taking ondansetron. These include, but are not limited to, 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.
Key Trial Info
Start Date :
June 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03239210
Start Date
June 16 2017
End Date
May 16 2022
Last Update
May 3 2024
Active Locations (2)
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1
New York University School of Medicine
New York, New York, United States, 10016
2
The Nathan S. Kline Institute for Psychiatric Research
New York, New York, United States, 10962