Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study|
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 6th 12th week ] [ Designated as safety issue: No ]
- clinical global impression (CGI) [ Time Frame: 6th e 12th ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
ondansetron hydrochloride (oral solution) dosage of 0.25 mg twice a day for 6 weeks followed by 0,5 mg twice a day for 6 weeks for a total observation period of 12 weeks.
Other Name: Zofran
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796497
|Institute of Neuroscience|
|Florence, Italy, 50122|
|Principal Investigator:||Stefano Pallanti, MD||Istituto di Neuroscienze|