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Study of Fluconazole in Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fluconazole

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female participants, three to ten years of age.
Meets clinical criteria for an autism spectrum disorder.
No antifungal use in the preceding 3 months.
Results of pyrosequencing analysis that have identified yeast
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:

History of allergic reaction to fluconazole or other azole antifungal agents
Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus
History of uncontrolled epilepsy
Weight less than 15 kg at screening
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.
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.

Sites / Locations

Center for Autism and Related DisordersRecruiting
International Child Development Resource CenterRecruiting
Thoughtful HouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluconazole

Placebo

Arm Description

Placebo capsule daily for 30 days

Outcomes

Primary Outcome Measures

PDD Behavior Inventory

Secondary Outcome Measures

Full Information

NCT ID

NCT00936182

First Posted

July 7, 2009

Last Updated

July 8, 2009

Sponsor

The Center for Autism and Related Disorders

Collaborators

The International Child Development Resource Center, Thoughtful House

1. Study Identification

Unique Protocol Identification Number

NCT00936182

Brief Title

Study of Fluconazole in Children With Autism Spectrum Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2010 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Center for Autism and Related Disorders

Collaborators

The International Child Development Resource Center, Thoughtful House

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluconazole

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsule daily for 30 days

Intervention Type

Drug

Intervention Name(s)

Fluconazole

Other Intervention Name(s)

Diflucan

Intervention Description

Fluconazole daily for 30 days

Primary Outcome Measure Information:

Title

PDD Behavior Inventory

Time Frame

End of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female participants, three to ten years of age. Meets clinical criteria for an autism spectrum disorder. No antifungal use in the preceding 3 months. Results of pyrosequencing analysis that have identified yeast 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: History of allergic reaction to fluconazole or other azole antifungal agents Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus History of uncontrolled epilepsy Weight less than 15 kg at screening 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Scott Allen

Phone

(866) 833-3898

Ext

106

M.Allen@centerforautism.com

Facility Information:

Facility Name

Center for Autism and Related Disorders

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Doreen Granpeesheh, PhD

Facility Name

International Child Development Resource Center

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32904

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Rossignol, MD

First Name & Middle Initial & Last Name & Degree

Daniel Rossignol, MD

Facility Name

Thoughtful House

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Jepson, MD

First Name & Middle Initial & Last Name & Degree

Brian Jepson, MD

12. IPD Sharing Statement

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Study of Fluconazole in Children With Autism Spectrum Disorder

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