Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD) - Full Text View

Sponsor:	Institute of Neuroscience, Florence, Italy
Information provided by:	Institute of Neuroscience, Florence, Italy
ClinicalTrials.gov Identifier:	NCT00796497

Purpose

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.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: ondansetron	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by Institute of Neuroscience, Florence, Italy:

Primary Outcome Measures:

Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 6th 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical global impression (CGI) [ Time Frame: 6th e 12th ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	March 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ondansetron	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. Other Name: Zofran

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796497

Locations

Italy
Institute of Neuroscience
Florence, Italy, 50122

Sponsors and Collaborators

Institute of Neuroscience, Florence, Italy

Investigators

Principal Investigator:

Stefano Pallanti, MD

Istituto di Neuroscienze

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 1;23(12):1047-55.

Responsible Party:	Stefano Pallanti, Institute of Neuroscience
ClinicalTrials.gov Identifier:	NCT00796497 History of Changes
Other Study ID Numbers:	ONDAN-1
Study First Received:	November 20, 2008
Last Updated:	February 23, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Institute of Neuroscience, Florence, Italy:

Obsessive Compulsive Disorder
5-ht3
ondansetron

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 23, 2012