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Ondansetron Augmentation in Treatment-resistant OCD

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ClinicalTrials.gov Identifier: NCT01303536
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Ondansetron Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron Augmentation in Treatment-resistant OCD
Study Start Date : December 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale [ Time Frame: baseline ]
  2. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 2 ]
  3. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 4 ]
  4. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 6 ]
  5. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 8 ]
  6. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 10 ]
  7. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 12 ]
  8. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 14 ]
  9. Yale Brown Obsessive Compulsive Scale [ Time Frame: week 16 ]

Secondary Outcome Measures :
  1. The Drug Effect scale [ Time Frame: week 0 ]
  2. The Drug Effect scale [ Time Frame: week 2 ]
  3. The Drug Effect scale [ Time Frame: week 4 ]
  4. The Drug Effect scale [ Time Frame: week 6 ]
  5. The Drug Effect scale [ Time Frame: week 8 ]
  6. The Drug Effect scale [ Time Frame: week 10 ]
  7. The Drug Effect scale [ Time Frame: week 12 ]
  8. The Drug Effect scale [ Time Frame: week 14 ]
  9. The Drug Effect scale [ Time Frame: week 16 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01303536


Locations
Italy
Institute of Neuroscience
Florence, Italy, 50137
Sponsors and Collaborators
Institute of Neuroscience, Florence, Italy
Investigators
Principal Investigator: Stefano Pallanti, MD University of Florence
More Information

Responsible Party: Stefano Pallanti, University of Florence
ClinicalTrials.gov Identifier: NCT01303536     History of Changes
Other Study ID Numbers: OND2
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Ondansetron
Serotonin
Serotonin Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Serotonin Receptor Agonists
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators