Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Drug: ondansetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ondansetron<br> | Drug: ondansetron<br>* 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.<br>* Other names: Zofran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | 6th 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical global impression (CGI) |  | 6th e 12th | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive Compulsive Disorder, 5-ht3, ondansetron