Study of Fluconazole in Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants, three to ten years of age. Meets clinical criteria for an autism spectrum disorder. No antifungal use in the preceding 3 months. Results of pyrosequencing analysis that have identified yeast Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study and must provide written consent to study protocol. Exclusion Criteria: History of allergic reaction to fluconazole or other azole antifungal agents Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus History of uncontrolled epilepsy Weight less than 15 kg at screening Presence of a chronic medical condition that might interfere with study participation or where study participation would be contraindicated or clinically significant abnormal baseline laboratory results. Recent (less than two months prior to study entry) initiation of behavior therapy 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluconazole<br> | Drug: Fluconazole<br>* Fluconazole daily for 30 days<br>* Other names: Diflucan;|
| Placebo Comparator: Placebo<br>Placebo capsule daily for 30 days | Drug: Fluconazole<br>* Fluconazole daily for 30 days<br>* Other names: Diflucan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDD Behavior Inventory |  | End of study |