Obsessive Compulsive Disorder
Conditions
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.
Interventions
DRUGOndansetron
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
Sponsors
Institute of Neuroscience, Florence, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale Brown Obsessive Compulsive Scale | baseline |
Secondary
| Measure | Time frame |
|---|---|
| The Drug Effect scale | week 0 |
Countries
Italy
Outcome results
None listed