Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03239210
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

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 (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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Tic Disorders Tourette Syndrome Drug: Ondansetron Drug: Placebo Phase 4

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 visceral organs in Tic/Tourette's Disorders, OCD patients with symptoms of "not just right experiences" or disgust sensitivity, and other disorders such as trichotillomania or excoriation disorder. In OCD, these 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, abnormality of which may be related to sensory phenomena. Research has revealed a cortical interoceptive circuit involving insula, anterior cingulate cortex (ACC), and sensorimotor cortex. Ondansetron (OND) is a good candidate for the modulation of the above-described interoceptive circuit. It is a selective 5-HT3 (serotonin) receptor antagonist that acts on both peripheral and central receptors. OND has long been used to treat nausea and vomiting due to chemotherapy, radiation therapy, anesthesia, and opioid-induced emesis. It has also been used alone or as adjunctive therapy for the treatment of both OCD and Tourette's disorder, showing some efficacy in small clinical trials. The mechanisms by which ondansetron improves symptoms in OCD and tic disorders are unknown, although the investigator's earlier study found that single doses of ondansetron reduce activation of insula and somatosensory cortex in healthy controls. As a follow-up to this work, the current protocol will compare the effects of 24 mg/day of ondansetron vs. placebo for 4 weeks in patients with OCD or Tic Disorders on symptoms and brain functioning.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ondansetron in Obsessive-compulsive and Tic Disorders
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ondansetron (OND)
24 mg/day for 4 weeks
Drug: Ondansetron
5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting
Other Name: Zofran

Placebo Comparator: Placebo (PL)
Placebo pill
Drug: Placebo
placebo equivalent




Primary Outcome Measures :
  1. Change in Sensory phenomena severity from baseline to 4 weeks [ Time Frame: baseline and 4 weeks ]
    Sensory phenomena scale, Minimum: 0, Maximum: 15, higher scores indicate more severe sensory phenomena


Secondary Outcome Measures :
  1. Percent BOLD signal change [ Time Frame: baseline and 4 weeks ]
    Change in brain activation as measured by % blood-oxygen-level dependent (BOLD) signal change in insula and sensorimotor cortex from baseline to 4 weeks

  2. Patient-Related Inventory of Side effects [ Time Frame: baseline and 4 weeks ]
    Using the Patient-Rated Inventory of Side effects, greater endorsement indicates more side effects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239210


Contacts
Layout table for location contacts
Contact: Carina Brown 212-404-3919 carina.brown@nyumc.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Carina Brown    212-404-3919    carina.brown@nyumc.org   
Principal Investigator: Emily Stern, PhD         
The Nathan S. Kline Institute for Psychiatric Research Recruiting
New York, New York, United States, 10962
Contact: Carina Brown    212-404-3919    carina.brown@nyumc.org   
Contact: Carina Brown    845-398-6563    carina.brown@nki.rfmh.org   
Principal Investigator: Emily Stern, MD         
Sponsors and Collaborators
NYU Langone Health
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Emily Stern, PhD NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03239210     History of Changes
Other Study ID Numbers: 17-01608
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data Sharing Plan The project will be registered and results reported on ClinicalTrials.gov. Neuroimaging data and associated files (e.g. behavioral response data generated during tasks) will be de-identified and provided for use by other researchers. De-identification will include removal of sensitive data from image file headers (e.g. name, date of birth). The anonymized final data set will be made available upon request, with an announcement on the lab website providing information on how to obtain the data. In addition, final data will be uploaded to an appropriate public database, such as the Open fMRI project, for broad availability. Data sharing will comply with local, state, and federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), as well as institutional policies and review
Time Frame: Data will be made available when the study team has published the outcomes of our primary and secondary analyses.
Access Criteria: A written request must be made to the PI for access to the data. This request will involve providing an abstract detailing the planned analyses and utilization of the data and a signed agreement not to share the data with any other person.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
Brain Function
functional magnetic resonance imaging (fMRI)
Sensory processing
Obsessive-Compulsive Disorder
OCD
Additional relevant MeSH terms:
Layout table for MeSH terms
Tourette Syndrome
Psychotropic Drugs
Tics
Tic Disorders
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics