Ondansetron Augmentation in Treatment-resistant OCD

Obsessive Compulsive Disorder Clinical Trial

Official title:

Ondansetron Augmentation in Treatment-resistant OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303536
• Other study ID #: OND2
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2011
• Last updated: February 23, 2011
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2011
• Source: Institute of Neuroscience, Florence, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
Italy	Institute of Neuroscience	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Neuroscience, Florence, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale		baseline	No
Primary	Yale Brown Obsessive Compulsive Scale		week 2	No
Primary	Yale Brown Obsessive Compulsive Scale		week 4	No
Primary	Yale Brown Obsessive Compulsive Scale		week 6	No
Primary	Yale Brown Obsessive Compulsive Scale		week 8	No
Primary	Yale Brown Obsessive Compulsive Scale		week 10	No
Primary	Yale Brown Obsessive Compulsive Scale		week 12	No
Primary	Yale Brown Obsessive Compulsive Scale		week 14	No
Primary	Yale Brown Obsessive Compulsive Scale		week 16	No
Secondary	The Drug Effect scale		week 0	Yes
Secondary	The Drug Effect scale		week 2	Yes
Secondary	The Drug Effect scale		week 4	Yes
Secondary	The Drug Effect scale		week 6	Yes
Secondary	The Drug Effect scale		week 8	Yes
Secondary	The Drug Effect scale		week 10	Yes
Secondary	The Drug Effect scale		week 12	Yes
Secondary	The Drug Effect scale		week 14	Yes
Secondary	The Drug Effect scale		week 16	Yes