Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Information source: Institute of Neuroscience, Florence, Italy
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: ondansetron (Drug)
Phase: Phase 4
Sponsored by: Institute of Neuroscience, Florence, Italy
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
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)
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.
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)
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
Locations and Contacts
Institute of Neuroscience, Florence 50122, Italy; Recruiting
Stefano Pallanti, MD, Phone: 055575716, Email: firstname.lastname@example.org
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: November 25, 2008