Randomized controlled trial of the effects of high-dose ondansetron on clinical symptoms and brain connectivity in obsessive-compulsive and tic disorders
Abstract
Objective: Sensory phenomena (SP) are aversive sensations driving repetitive behaviors in obsessive-compulsive disorder (OCD) and Tourette’s disorder (TD) that are not well addressed by standard treatments. SP are related to functioning of an interoceptive-sensorimotor circuit that may be modulated by the 5-HT3 receptor antagonist ondansetron. The present study employed an experimental medicine approach testing the effects of 4 weeks of high-dose ondansetron (24 mg, n=27) compared to placebo (n=24) on SP severity and brain connectivity in a cohort of individuals with OCD and/or TD. Methods: Analyses examined changes in SP severity and, for OCD participants, overall OCD severity from Baseline to Final visits. Functional magnetic resonance imaging (fMRI) data were collected at both visits for analysis of intrinsic functional connectivity metrics characterizing global correlation (reflecting area “hubness”) and local correlation (reflecting near-neighbor coherence). Results: There were no significant differences between ondansetron and placebo in the reduction of SP or overall OCD severity in the full sample. In a subsample of OCD participants taking concomitant serotonin-reuptake inhibitors (SRIs), ondansetron significantly decreased overall OCD severity and global connectivity of medial sensorimotor cortex more than placebo. Longitudinal reductions in SP severity were related to decreases in right sensorimotor hubness in both groups and brainstem local coherence only in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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