Ondansetron Augmentation in Treatment-resistant OCD
This study has been completed.
Sponsor:
Institute of Neuroscience, Florence, Italy
Information provided by:
Institute of Neuroscience, Florence, Italy
ClinicalTrials.gov Identifier:
NCT01303536
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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Purpose
The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: Ondansetron |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ondansetron Augmentation in Treatment-resistant OCD |
Resource links provided by NLM:
Further study details as provided by Institute of Neuroscience, Florence, Italy:
Primary Outcome Measures:
- Yale Brown Obsessive Compulsive Scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 2 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 4 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 6 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 8 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 14 ] [ Designated as safety issue: No ]
- Yale Brown Obsessive Compulsive Scale [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The Drug Effect scale [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 10 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 14 ] [ Designated as safety issue: Yes ]
- The Drug Effect scale [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: obsessive compulsive disorder
obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly
|
Drug: Ondansetron
obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
- a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
- a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose
Exclusion Criteria:
- diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
- undergoing concomitant behavior therapy
- or having significant cardiovascular, hepatic, renal or pulmonary diseases
Contacts and Locations More Information
No publications provided
| Responsible Party: | Stefano Pallanti, University of Florence |
| ClinicalTrials.gov Identifier: | NCT01303536 History of Changes |
| Other Study ID Numbers: | OND2 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Ondansetron Serotonin Uptake Inhibitors 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 Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013