Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

NCT03239210 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-01608
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Obsessive-Compulsive Disorder; Tic Disorders; Tourette Syndrome

Keywords

Brain Function; functional magnetic resonance imaging (fMRI); Sensory processing; Obsessive-Compulsive Disorder; OCD

Outcome Measures

Primary Outcomes (2)

• Change in Brain Activation - Insula Cortex

  Change in brain activation is measured by parameter estimate of blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.

  Baseline, Week 4

• Change in Brain Activation - Somatosensory Cortex

  Change in brain activation is measured by parameter estimate of blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.

  Baseline, Week 4

Secondary Outcomes (3)

• Change in Sensory Phenomena Scale (SPS) Score

  Baseline, Week 4

• Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score

  Baseline, Week 4

• Change in Yale Global Tic Severity Scale (YGTSS) Score

  Baseline, Week 4

Study Arms (2)

Ondansetron (OND)

ACTIVE COMPARATOR

24 mg/day for 4 weeks

Drug: Ondansetron

Placebo (PL)

PLACEBO COMPARATOR

Placebo pill

Drug: Placebo

Interventions

Ondansetron DRUG

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

Also known as: Zofran

Ondansetron (OND)

Placebo DRUG

placebo equivalent

Placebo (PL)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

New York University School of Medicine

New York, New York, 10016, United States

Location

The Nathan S. Kline Institute for Psychiatric Research

New York, New York, 10962, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Tic Disorders; Tourette Syndrome

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Results Point of Contact

• Title: Nicolette Recchia
• Organization: NYU Langone Health

nicolette.recchia@nyulangone.org

845-398-6563

Study Officials

• Emily Stern, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: June 16, 2017
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 3, 2024
• Results First Posted: July 3, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)