Status:
COMPLETED
Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Lead Sponsor:
Institute of Neuroscience, Florence, Italy
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistan...
Detailed Description
METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron in...
Eligibility Criteria
Inclusion
- adults aged 18 to 55
- a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)
Exclusion
- a history of alcohol or substance abuse
- current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
- heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
- hoarding as only Obsessive Compulsive symptom
- women of childbearing potential not using a medically acceptable contraceptive method.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00796497
Start Date
March 1 2008
End Date
December 1 2008
Last Update
February 24 2011
Active Locations (1)
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1
Institute of Neuroscience
Florence, Italy, Italy, 50122