Study of Fluconazole in Children With Autism Spectrum Disorder
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by The Center for Autism and Related Disorders.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Center for Autism and Related Disorders
Collaborators:
The International Child Development Resrouce Center
Thoughtful House
Information provided by:
The Center for Autism and Related Disorders
ClinicalTrials.gov Identifier:
NCT00936182
First received: July 7, 2009
Last updated: July 8, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Autism Spectrum Disorder |
Drug: Fluconazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder |
Resource links provided by NLM:
Further study details as provided by The Center for Autism and Related Disorders:
Primary Outcome Measures:
- PDD Behavior Inventory [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fluconazole |
Drug: Fluconazole
Fluconazole daily for 30 days
Other Name: Diflucan
|
|
Placebo Comparator: Placebo
Placebo capsule daily for 30 days
|
Drug: Fluconazole
Fluconazole daily for 30 days
Other Name: Diflucan
|
Eligibility| Ages Eligible for Study: | 3 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936182
Contacts
| Contact: Scott Allen | (866) 833-3898 ext 106 | M.Allen@centerforautism.com |
Locations
| United States, California | |
| Center for Autism and Related Disorders | Recruiting |
| Tarzana, California, United States, 91356 | |
| Principal Investigator: Doreen Granpeesheh, PhD | |
| United States, Florida | |
| International Child Development Resource Center | Recruiting |
| Melbourne, Florida, United States, 32904 | |
| Contact: Daniel Rossignol, MD | |
| Principal Investigator: Daniel Rossignol, MD | |
| United States, Texas | |
| Thoughtful House | Recruiting |
| Austin, Texas, United States, 78746 | |
| Contact: Brian Jepson, MD | |
| Principal Investigator: Brian Jepson, MD | |
Sponsors and Collaborators
The Center for Autism and Related Disorders
The International Child Development Resrouce Center
Thoughtful House
More Information
No publications provided
| Responsible Party: | Daniel Rossignol, ICDRC |
| ClinicalTrials.gov Identifier: | NCT00936182 History of Changes |
| Other Study ID Numbers: | C0901 |
| Study First Received: | July 7, 2009 |
| Last Updated: | July 8, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Fluconazole Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013