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| Name | Class |
|---|---|
| The International Child Development Resource Center | OTHER |
| Thoughtful House | OTHER |
Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The current investigation will examine the effects of fluconazole on behavioral functioning among children with ASD. This is a double-blind, randomized, placebo-controlled study of oral fluconazole in children who meet criteria for ASD. Pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of fluconazole therapy. In addition, children will undergo comprehensive medical history, physical examination, and laboratory analyses.
Our objective is to quantify differences in behavioral functioning between the fluconazole treatment and a placebo. Our primary hypothesis is that, on average and relative to the placebo, children with ASD who receive fluconazole will show greater improvements in symptoms of autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluconazole | Experimental |
| |
| Placebo | Placebo Comparator | Placebo capsule daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | Fluconazole daily for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| PDD Behavior Inventory | End of study |
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Inclusion Criteria:
Exclusion Criteria:
A child will be excluded at any point during the study if it is revealed that a major change (either addition or deletion) of treatment or service provision has occurred.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott Allen | Contact | (866) 833-3898 | 106 | M.Allen@centerforautism.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Autism and Related Disorders | Recruiting | Tarzana | California | 91356 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| International Child Development Resource Center | Recruiting | Melbourne | Florida | 32904 | United States |
|
| Thoughtful House | Recruiting | Austin | Texas | 78746 | United States |
|