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Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Information source: Institute of Neuroscience, Florence, Italy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: ondansetron (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Institute of Neuroscience, Florence, Italy

Official(s) and/or principal investigator(s):
Stefano Pallanti, MD, Principal Investigator, Affiliation: Istituto di Neuroscienze


Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.

Clinical Details

Official title: Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary outcome: clinical global impression (CGI)

Detailed description: METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0. 25 mg twice daily for 6 weeks, that will be titrated to 0. 5 mg twice daily for 6 weeks.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria: 1. adults aged 18 to 55 2. a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day) Exclusion Criteria: 1. a history of alcohol or substance abuse 2. current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions 3. heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease 4. hoarding as only Obsessive Compulsive symptom 5. women of childbearing potential not using a medically acceptable contraceptive method.

Locations and Contacts

Institute of Neuroscience, Florence 50122, Italy
Additional Information

Related publications:

Hewlett WA, Schmid SP, Salomon RM. Pilot trial of ondansetron in the treatment of 8 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003 Sep;64(9):1025-30.

Starting date: March 2008
Last updated: February 23, 2011

Page last updated: August 23, 2015

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