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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obsessive compulsive disorder | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Drug Effect scale | week 0 | |
| The Drug Effect scale | week 2 | |
| The Drug Effect scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Pallanti, MD | University of Florence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neuroscience | Florence | Florence | 50137 | Italy |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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 |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |