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

The Center for Autism and Related Disorders3 sites in 1 country50 target enrollmentJuly 2009

ConditionsAutism Spectrum Disorder

InterventionsFluconazole

DrugsFluconazole

Overview

Phase: N/A
Intervention: Fluconazole
Conditions: Autism Spectrum Disorder
Sponsor: The Center for Autism and Related Disorders
Enrollment: 50
Locations: 3
Primary Endpoint: PDD Behavior Inventory
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

July 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Center for Autism and Related Disorders

Eligibility Criteria

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.