Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

NCT ID: NCT00796497

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-12-31

Brief 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.

Detailed 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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ondansetron

Group Type: EXPERIMENTAL

ondansetron

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zofran

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Neuroscience, Florence, Italy

OTHER

Sponsor Role: lead

Responsible Party

Institute of Neuroscience

Principal Investigators

Stefano Pallanti, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto di Neuroscienze

Locations

Institute of Neuroscience

Florence, Italy, Italy

Countries

Italy

References

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. doi: 10.4088/jcp.v64n0907.

Reference Type: BACKGROUND

PMID: 14628977 (View on PubMed)

Pallanti S, Bernardi S, Antonini S, Singh N, Hollander E. Ondansetron augmentation in treatment-resistant obsessive-compulsive disorder: a preliminary, single-blind, prospective study. CNS Drugs. 2009 Dec;23(12):1047-55. doi: 10.2165/11530240-000000000-00000.

Reference Type: DERIVED

PMID: 19958042 (View on PubMed)

Other Identifiers

ONDAN-1

Identifier Type: -

Identifier Source: org_study_id