Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796497
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : February 24, 2011
Information provided by:
Institute of Neuroscience, Florence, Italy

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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: ondansetron Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study
Study Start Date : March 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 6th 12th week ]

Secondary Outcome Measures :
  1. clinical global impression (CGI) [ Time Frame: 6th e 12th ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796497

Institute of Neuroscience
Florence, Italy, 50122
Sponsors and Collaborators
Institute of Neuroscience, Florence, Italy
Principal Investigator: Stefano Pallanti, MD Istituto di Neuroscienze

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stefano Pallanti, Institute of Neuroscience Identifier: NCT00796497     History of Changes
Other Study ID Numbers: ONDAN-1
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Institute of Neuroscience, Florence, Italy:
Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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