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Ondansetron Augmentation in Treatment-resistant OCD

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
Institute of Neuroscience, Florence, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Neuroscience

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

obsessive compulsive disorder

Arm Description

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

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale
Yale Brown Obsessive Compulsive Scale

Secondary Outcome Measures

The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale
The Drug Effect scale

Full Information

First Posted
February 23, 2011
Last Updated
February 23, 2011
Sponsor
Institute of Neuroscience, Florence, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01303536
Brief Title
Ondansetron Augmentation in Treatment-resistant OCD
Official Title
Ondansetron Augmentation in Treatment-resistant OCD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Neuroscience, Florence, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obsessive compulsive disorder
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
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 Measure Information:
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
baseline
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 2
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 4
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 6
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 8
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 10
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 12
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 14
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
week 16
Secondary Outcome Measure Information:
Title
The Drug Effect scale
Time Frame
week 0
Title
The Drug Effect scale
Time Frame
week 2
Title
The Drug Effect scale
Time Frame
week 4
Title
The Drug Effect scale
Time Frame
week 6
Title
The Drug Effect scale
Time Frame
week 8
Title
The Drug Effect scale
Time Frame
week 10
Title
The Drug Effect scale
Time Frame
week 12
Title
The Drug Effect scale
Time Frame
week 14
Title
The Drug Effect scale
Time Frame
week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Pallanti, MD
Organizational Affiliation
University of Florence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience
City
Florence
ZIP/Postal Code
50137
Country
Italy

12. IPD Sharing Statement

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Ondansetron Augmentation in Treatment-resistant OCD

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