Ondansetron Augmentation in Treatment-resistant OCD

This study has been completed.

Sponsor:

Information provided by:

Institute of Neuroscience, Florence, Italy

ClinicalTrials.gov Identifier:

NCT01303536

First received: February 23, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 23, 2011

Last Updated Date

February 23, 2011

Start Date ^ICMJE

December 2009

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Yale Brown Obsessive Compulsive Scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 2 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 14 ] [ Designated as safety issue: No ]
Yale Brown Obsessive Compulsive Scale [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

The Drug Effect scale [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 10 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 14 ] [ Designated as safety issue: Yes ]
The Drug Effect scale [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ondansetron Augmentation in Treatment-resistant OCD

Official Title ^ICMJE

Ondansetron Augmentation in Treatment-resistant OCD

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Drug: 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

Study Arm (s)

Experimental: obsessive compulsive disorder

Intervention: Drug: Ondansetron

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01303536

Other Study ID Numbers ^ICMJE

OND2

Has Data Monitoring Committee

Yes

Responsible Party

Stefano Pallanti, University of Florence

Study Sponsor ^ICMJE

Institute of Neuroscience, Florence, Italy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefano Pallanti, MD

University of Florence

Information Provided By

Institute of Neuroscience, Florence, Italy

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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