Ondansetron Augmentation in Treatment-resistant OCD

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Drug: Ondansetron

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50137
    • Institute of Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale Brown Obsessive Compulsive Scale	baseline
Yale Brown Obsessive Compulsive Scale	week 2
Yale Brown Obsessive Compulsive Scale	week 4
Yale Brown Obsessive Compulsive Scale	week 6
Yale Brown Obsessive Compulsive Scale	week 8
Yale Brown Obsessive Compulsive Scale	week 10
Yale Brown Obsessive Compulsive Scale	week 12
Yale Brown Obsessive Compulsive Scale	week 14
Yale Brown Obsessive Compulsive Scale	week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
The Drug Effect scale	week 0
The Drug Effect scale	week 2
The Drug Effect scale	week 4
The Drug Effect scale	week 6
The Drug Effect scale	week 8
The Drug Effect scale	week 10
The Drug Effect scale	week 12
The Drug Effect scale	week 14
The Drug Effect scale	week 16

Collaborators and Investigators

• Sponsor: Institute of Neuroscience, Florence, Italy
• Investigators: Principal Investigator: Stefano Pallanti, MD, University of Florence

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (ESTIMATE): February 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: OND2