Study of Fluconazole in Children With Autism Spectrum Disorder

Not Applicable

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: Fluconazole

• Registration Number: NCT00936182
• Lead Sponsor: The Center for Autism and Related Disorders

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Last Update Submitted: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Posted: 2009-07-09
• Primary Completion: 2010-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female participants, three to ten years of age.
2. Meets clinical criteria for an autism spectrum disorder.
3. No antifungal use in the preceding 3 months.
4. Results of pyrosequencing analysis that have identified yeast
5. 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

1. History of allergic reaction to fluconazole or other azole antifungal agents
2. Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus
3. History of uncontrolled epilepsy
4. Weight less than 15 kg at screening
5. 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.
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	-
Placebo	Fluconazole	Placebo capsule daily for 30 days

Primary Outcome Measures

Name	Time	Method
PDD Behavior Inventory	End of study

Trial Locations

Locations (3)

International Child Development Resource Center; 🇺🇸 Melbourne, Florida, United States

Thoughtful House; 🇺🇸 Austin, Texas, United States

Center for Autism and Related Disorders; 🇺🇸 Tarzana, California, United States