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
1 other identifier
interventional
50
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2009
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 9, 2009
July 1, 2009
1 year
July 7, 2009
July 8, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
PDD Behavior Inventory
End of study
Study Arms (2)
Fluconazole
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo capsule daily for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Center for Autism and Related Disorderslead
- The International Child Development Resource Centercollaborator
- Thoughtful Housecollaborator
Study Sites (3)
Center for Autism and Related Disorders
Tarzana, California, 91356, United States
International Child Development Resource Center
Melbourne, Florida, 32904, United States
Thoughtful House
Austin, Texas, 78746, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 9, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2011
Last Updated
July 9, 2009
Record last verified: 2009-07