Study of Fluconazole in Children With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936182
Recruitment Status : Unknown
Verified July 2009 by The Center for Autism and Related Disorders.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : July 9, 2009
The International Child Development Resource Center
Thoughtful House
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Fluconazole Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder
Study Start Date : July 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluconazole Drug: Fluconazole
Fluconazole daily for 30 days
Other Name: Diflucan
Placebo Comparator: Placebo
Placebo capsule daily for 30 days
Drug: Fluconazole
Fluconazole daily for 30 days
Other Name: Diflucan

Primary Outcome Measures :
  1. PDD Behavior Inventory [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00936182

Contact: Scott Allen (866) 833-3898 ext 106

United States, California
Center for Autism and Related Disorders Recruiting
Tarzana, California, United States, 91356
Principal Investigator: Doreen Granpeesheh, PhD         
United States, Florida
International Child Development Resource Center Recruiting
Melbourne, Florida, United States, 32904
Contact: Daniel Rossignol, MD         
Principal Investigator: Daniel Rossignol, MD         
United States, Texas
Thoughtful House Recruiting
Austin, Texas, United States, 78746
Contact: Brian Jepson, MD         
Principal Investigator: Brian Jepson, MD         
Sponsors and Collaborators
The Center for Autism and Related Disorders
The International Child Development Resource Center
Thoughtful House

Responsible Party: Daniel Rossignol, ICDRC Identifier: NCT00936182     History of Changes
Other Study ID Numbers: C0901
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors