Back to resultsOndansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, 5-ht3, ondansetron
Eligibility Criteria
Inclusion Criteria:
- adults aged 18 to 55
- 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:
- a history of alcohol or substance abuse
- current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
- heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
- hoarding as only Obsessive Compulsive symptom
- women of childbearing potential not using a medically acceptable contraceptive method.
Sites / Locations
- Institute of Neuroscience
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ondansetron
Arm Description
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
clinical global impression (CGI)
Full Information
NCT ID
NCT00796497
First Posted
November 20, 2008
Last Updated
February 23, 2011
Sponsor
Institute of Neuroscience, Florence, Italy
1. Study Identification
Unique Protocol Identification Number
NCT00796497
Brief Title
Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Official Title
Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Neuroscience, Florence, Italy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, 5-ht3, ondansetron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ondansetron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
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.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
6th 12th week
Secondary Outcome Measure Information:
Title
clinical global impression (CGI)
Time Frame
6th e 12th
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults aged 18 to 55
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:
a history of alcohol or substance abuse
current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
hoarding as only Obsessive Compulsive symptom
women of childbearing potential not using a medically acceptable contraceptive method.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Pallanti, MD
Organizational Affiliation
Istituto di Neuroscienze
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience
City
Florence
ZIP/Postal Code
50122
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
14628977
Citation
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. doi: 10.4088/jcp.v64n0907.
Results Reference
background
PubMed Identifier
19958042
Citation
Pallanti S, Bernardi S, Antonini S, Singh N, Hollander E. Ondansetron augmentation in treatment-resistant obsessive-compulsive disorder: a preliminary, single-blind, prospective study. CNS Drugs. 2009 Dec;23(12):1047-55. doi: 10.2165/11530240-000000000-00000.
Results Reference
derived
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Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
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