Autism Spectrum Disorder Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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