Status:
COMPLETED
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Cumberland Pharmaceuticals
Norton Healthcare
Conditions:
Autism
Severe Behavior Disorder
Eligibility:
All Genders
5-16 years
Phase:
NA
Brief Summary
This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have se...
Detailed Description
This is a prospective, single center, double-blind, randomized pilot study in children and adolescents with autism and severe behavior disorders. All subjects will undergo initial screening procedures...
Eligibility Criteria
Inclusion
- Age 5 to 16 years, inclusive
- Diagnosed with autism using the ADI-R (Autism Diagnostic Interview-Revised)
- ABC Irritability/Agitation subscale score (Aberrant Behavior Checklist Subscale) ≥ 18
- CGI-S score (Clinical Global Impression-Severity Scale) ≥ 4
- Must be drug naïve or on a stable dose of medication(s) and educational/behavioral interventions for one month prior to participation
- Parent/legal guardian must provide written consent and required research authorization (i.e. HIPAA) prior to the performance of any study procedures.
Exclusion
- Presence of another disorder on the autism spectrum including PDD-NOS (Pervasive Developmental Disorder Not Otherwise Specified), Asperger's, and Rett's Syndrome
- Patient with a known cause of autism such as Fragile X
- Evidence of significant renal dysfunction (e.g. GFR estimated by the Schwartz formula \< 50 mL/min or serum creatinine \> 2.5 X upper limit of normal for age)
- Evidence of significant hepatic dysfunction (serum transaminases \> 2.5 X the upper limit of normal)
- Known hypersensitivity to glutathione, vitamin C or NAC
- Pregnant or lactating female
- Inability of subject and parent to be able to comply with requirements for study visits and procedures
- Presence of major mental illness
- History of antioxidant supplementation.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00889538
Start Date
April 1 2009
End Date
September 1 2012
Last Update
December 7 2016
Active Locations (1)
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1
KCPCRU
Louisville, Kentucky, United States, 40202