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Ondansetron Augmentation in Treatment-resistant OCD

This study has been completed.
Sponsor:
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
  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: 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 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 2 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 4 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 6 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 8 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 10 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 12 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 14 ]
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: week 16 ]

Secondary Outcome Measures:
  • The Drug Effect scale [ Time Frame: week 0 ]
  • The Drug Effect scale [ Time Frame: week 2 ]
  • The Drug Effect scale [ Time Frame: week 4 ]
  • The Drug Effect scale [ Time Frame: week 6 ]
  • The Drug Effect scale [ Time Frame: week 8 ]
  • The Drug Effect scale [ Time Frame: week 10 ]
  • The Drug Effect scale [ Time Frame: week 12 ]
  • The Drug Effect scale [ Time Frame: week 14 ]
  • The Drug Effect scale [ Time Frame: week 16 ]

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 23, 2011
Last Updated: February 23, 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

ClinicalTrials.gov processed this record on July 27, 2017