Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder Clinical Trial

Official title:

Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796497
• Other study ID #: ONDAN-1
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: February 23, 2011
• Start date: March 2008
• Est. completion date: December 2008

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

Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.

Description:

METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated to 0.5 mg twice daily for 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. adults aged 18 to 55

2. a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of = 20 after = 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after = 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)

Exclusion Criteria:

1. a history of alcohol or substance abuse

2. current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions

3. heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease

4. hoarding as only Obsessive Compulsive symptom

5. women of childbearing potential not using a medically acceptable contraceptive method.

Study Design

Allocation: Non-Randomized, 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
ondansetron hydrochloride (oral solution) dosage of 0.25 mg twice a day for 6 weeks followed by 0,5 mg twice a day for 6 weeks for a total observation period of 12 weeks.

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, 

References & Publications (1)

Hewlett WA, Schmid SP, Salomon RM. Pilot trial of ondansetron in the treatment of 8 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003 Sep;64(9):1025-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)		6th 12th week	No
Secondary	clinical global impression (CGI)		6th e 12th	No