Ondansetron Augmentation in Treatment-resistant OCD

Study Overview
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Brief Summary
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The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.

Official Title
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Ondansetron Augmentation in Treatment-resistant OCD

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: a diagnosis of OCD established by clinical interview with a licensed psychiatrist; a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose Exclusion Criteria: diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder undergoing concomitant behavior therapy or having significant cardiovascular, hepatic, renal or pulmonary diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: obsessive compulsive disorder<br>obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly | Drug: Ondansetron<br>* obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale |  | baseline | 
| Yale Brown Obsessive Compulsive Scale |  | week 2 | 
| Yale Brown Obsessive Compulsive Scale |  | week 4 | 
| Yale Brown Obsessive Compulsive Scale |  | week 6 | 
| Yale Brown Obsessive Compulsive Scale |  | week 8 | 
| Yale Brown Obsessive Compulsive Scale |  | week 10 | 
| Yale Brown Obsessive Compulsive Scale |  | week 12 | 
| Yale Brown Obsessive Compulsive Scale |  | week 14 | 
| Yale Brown Obsessive Compulsive Scale |  | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Drug Effect scale |  | week 0 | 
| The Drug Effect scale |  | week 2 | 
| The Drug Effect scale |  | week 4 | 
| The Drug Effect scale |  | week 6 | 
| The Drug Effect scale |  | week 8 | 
| The Drug Effect scale |  | week 10 | 
| The Drug Effect scale |  | week 12 | 
| The Drug Effect scale |  | week 14 | 
| The Drug Effect scale |  | week 16 |