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

February 23, 2011
February 23, 2011
December 2009
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ondansetron Augmentation in Treatment-resistant OCD
Ondansetron Augmentation in Treatment-resistant OCD

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
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
Experimental: obsessive compulsive disorder
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: Drug: Ondansetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01303536
OND2
Yes
Stefano Pallanti, University of Florence
Institute of Neuroscience, Florence, Italy
Not Provided
Principal Investigator: Stefano Pallanti, MD University of Florence
Institute of Neuroscience, Florence, Italy
February 2011

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