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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: 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
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

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:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Ondansetron
Serotonin Uptake Inhibitors
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014