Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

NCT00796497 | Completed Phase 4 DMC

• 1 other identifier: ONDAN-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder; 5-ht3; ondansetron

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  6th 12th week

Secondary Outcomes (1)

• clinical global impression (CGI)

  6th e 12th

Study Arms (1)

ondansetron

EXPERIMENTAL

Drug: ondansetron

Interventions

ondansetron 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.

Also known as: Zofran

ondansetron

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults aged 18 to 55
• 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)

You may not qualify if:

• a history of alcohol or substance abuse
• current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
• heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
• hoarding as only Obsessive Compulsive symptom
• women of childbearing potential not using a medically acceptable contraceptive method.

Sponsors & Collaborators

• Institute of Neuroscience, Florence, Italy: lead

Study Sites (1)

Institute of Neuroscience

Florence, Italy, 50122, Italy

Location

Related Publications (2)

• 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.

  PMID: 14628977 BACKGROUND

• 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.

  PMID: 19958042 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Stefano Pallanti, MD

  Istituto di Neuroscienze

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

IT (1)