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Study of Fluconazole in Children With Autism Spectrum Disorder

NCT00936182 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-07-09

No results posted yet for this study

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

Interventions

DRUG

Fluconazole

Fluconazole daily for 30 days

Sponsors & Collaborators

  • The International Child Development Resource Center

    collaborator OTHER

  • Thoughtful House

    collaborator OTHER

  • The Center for Autism and Related Disorders

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936182 on ClinicalTrials.gov