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

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: Fluconazole

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Allen; Phone Number: 106 (866) 833-3898; Email: M.Allen@centerforautism.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluconazole	Drug: Fluconazole; Fluconazole daily for 30 days; Other Names: Diflucan
Placebo Comparator: Placebo; Placebo capsule daily for 30 days	Drug: Fluconazole; Fluconazole daily for 30 days; Other Names: Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PDD Behavior Inventory	End of study

Collaborators and Investigators

• Sponsor: The Center for Autism and Related Disorders
• Collaborators: The International Child Development Resource Center; Thoughtful House

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2010
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: C0901