Recruiting

Fluconazole

Sponsor:

The Center for Autism and Related Disorders

Code:

NCT00936182

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Not accepted

Interventions

Fluconazole

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT00936182

Start date

Jul, 2009

Status verified date

Jul, 2009

Completion date

Jul, 2011

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fluconazole

placebo comparator: Placebo

Placebo capsule daily for 30 days

Interventions

Fluconazole

Fluconazole daily for 30 days

Primary outcome measure

  • PDD Behavior Inventory [ Time Frame: End of study ]

Central Contacts and Locations

Locations

Center for Autism and Related Disorders

Recruiting

Tarzana, California, United States, 91356

Principal Investigator:

Doreen Granpeesheh, PhD

International Child Development Resource Center

Recruiting

Melbourne, Florida, United States, 32904

Principal Investigator:

Daniel Rossignol, MD

Thoughtful House

Recruiting

Austin, Texas, United States, 78746

Principal Investigator:

Brian Jepson, MD

More Information

Sponsor

The Center for Autism and Related Disorders

Last update posted

Jul 9, 2009

Last verified

Jul, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The Center for Autism and Related Disorders on 2009-07-09.