Ondansetron Augmentation in Treatment-resistant OCD

Phase 4

Completed

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

• Registration Number: NCT01303536
• Lead Sponsor: Institute of Neuroscience, Florence, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-02
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Last Update Submitted: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
obsessive compulsive disorder	Ondansetron	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

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale	week 16

Secondary Outcome Measures

Name	Time	Method
The Drug Effect scale	week 16

Trial Locations

Locations (1)

Institute of Neuroscience; 🇮🇹 Florence, Italy