Study of Fluconazole in Children With Autism Spectrum Disorder
Information source: The Center for Autism and Related Disorders
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autism Spectrum Disorder
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The Center for Autism and Related Disorders Overall contact:
Scott Allen, Phone: (866) 833-3898, Ext: 106, Email: M.Allen@centerforautism.com
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: PDD Behavior Inventory
Eligibility
Minimum age: 3 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Scott Allen, Phone: (866) 833-3898, Ext: 106, Email: M.Allen@centerforautism.com
Center for Autism and Related Disorders, Tarzana, California 91356, United States; Recruiting
Doreen Granpeesheh, PhD, Principal Investigator
International Child Development Resource Center, Melbourne, Florida 32904, United States; Recruiting
Daniel Rossignol, MD
Daniel Rossignol, MD, Principal Investigator
Thoughtful House, Austin, Texas 78746, United States; Recruiting
Brian Jepson, MD
Brian Jepson, MD, Principal Investigator
Additional Information
Starting date: July 2009
Ending date: July 2011
Last updated: July 8, 2009
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