Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Phase 4

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Drug: ondansetron

• Registration Number: NCT00796497
• Lead Sponsor: Institute of Neuroscience, Florence, Italy

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Completion: 2008-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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)

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Exclusion Criteria

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 method.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ondansetron	ondansetron	-

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	6th 12th week

Secondary Outcome Measures

Name	Time	Method
clinical global impression (CGI)	6th e 12th

Trial Locations

Locations (1)

Institute of Neuroscience; 🇮🇹 Florence, Italy