Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
This study has been completed.
Sponsor:
Institute of Neuroscience, Florence, Italy
Information provided by:
Institute of Neuroscience, Florence, Italy
ClinicalTrials.gov Identifier:
NCT00796497
First received: November 20, 2008
Last updated: February 23, 2011
Last verified: February 2011
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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:
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 More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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, 2013