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| 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 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled Study of the Efficacy of Fluconazole as a Treatment for Autism Spectrum Disorder |
| 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 |
|---|---|
| Fluconazole: Experimental |
Drug: Fluconazole
Fluconazole daily for 30 days
|
|
Placebo: Placebo Comparator
Placebo capsule daily for 30 days
|
Drug: Fluconazole
Fluconazole daily for 30 days
|
Eligibility| Ages Eligible for Study: | 3 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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| Contact: Scott Allen | (866) 833-3898 ext 106 | M.Allen@centerforautism.com |
| 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 | |
More Information
| Responsible Party: | ICDRC ( Daniel Rossignol ) |
| Study ID Numbers: | C0901 |
| Study First Received: | July 7, 2009 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00936182 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fluconazole Child Development Disorders, Pervasive Anti-Infective Agents Pathologic Processes Disease Mental Disorders |
Autistic Disorder Therapeutic Uses Antifungal Agents Mental Disorders Diagnosed in Childhood Pharmacologic Actions |