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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
Sponsor:
Collaborators:
The International Child Development Resource Center
Thoughtful House
Information provided by:
The Center for Autism and Related Disorders
ClinicalTrials.gov Identifier:
NCT00936182
First received: July 7, 2009
Last updated: July 8, 2009
Last verified: July 2009
  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:


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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Resource 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
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014