Trial | NCT00936182  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
Jul 31
2009
Primary Completion
Jul 31
2010
Anticipated
Study Completion
Jul 31
2011
Anticipated
Last Update
Jul 09
2009
Estimate

Drug Fluconazole

Fluconazole daily for 30 days

  • Other names: Diflucan

Fluconazole Experimental

Placebo Placebo Comparator

Placebo capsule daily for 30 days

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.
No Results Posted