Study of Fluconazole in Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00936182
• Other study ID #: C0901
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: July 8, 2009
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2009
• Source: The Center for Autism and Related Disorders
• Contact: Scott Allen
• Phone: (866) 833-3898
• Email: M.Allen[@]centerforautism.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Fluconazole
Fluconazole daily for 30 days

Locations

Country	Name	City	State
United States	Thoughtful House	Austin	Texas
United States	International Child Development Resource Center	Melbourne	Florida
United States	Center for Autism and Related Disorders	Tarzana	California

Sponsors (3)

Lead Sponsor	Collaborator
The Center for Autism and Related Disorders	The International Child Development Resource Center, Thoughtful House

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDD Behavior Inventory		End of study	Yes