Study of Fluconazole in Children With Autism Spectrum Disorder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by The Center for Autism and Related Disorders. Recruitment status was Recruiting

First Received on July 7, 2009. Last Updated on July 8, 2009 History of Changes

Sponsor:	The Center for Autism and Related Disorders
Collaborators:	The International Child Development Resrouce Center Thoughtful House
Information provided by:	The Center for Autism and Related Disorders
ClinicalTrials.gov Identifier:	NCT00936182

Purpose

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	Intervention
Autism Spectrum Disorder	Drug: Fluconazole

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by The Center for Autism and Related Disorders:

Primary Outcome Measures:

PDD Behavior Inventory [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	3 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936182

Contacts

Contact: Scott Allen

(866) 833-3898 ext 106

M.Allen@centerforautism.com

Locations

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 Resrouce Center

Thoughtful House

More Information

No publications provided

Responsible Party:	Daniel Rossignol, ICDRC
ClinicalTrials.gov Identifier:	NCT00936182 History of Changes
Other Study ID Numbers:	C0901
Study First Received:	July 7, 2009
Last Updated:	July 8, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Fluconazole
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 08, 2012