drugset / Trial / NCT00936182

Study of Fluconazole in Children With Autism Spectrum Disorder

NCT00936182

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-07
Primary completion
2010-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule Oral