What is the purpose of the study?
The purpose of the study is to determine whether glutathione, a tripeptide with anti-inflammatory effects, is beneficial in treating severe behavioral concerns associated with autism.
What does participation in this study mean?
Participation involves weekly visits to receive either intravenous glutathione or placebo. Behavioral questionnaires are completed at each visit and blood work is obtained on several visits.
Who is eligible for participation in this study?
Children and adolescents between the ages of 5 and 17 who have both autism and severe behavior concerns are eligible for the study.
What is the time commitment for participation in the study?
The study requires weekly visits for a period of 18 weeks.
What are the potential benefits of participating in the study?
It may be helpful for some families to find out whether glutathione is effective in treating behavior problems of their child in case this might be a future treatment option. This information is also likely to be helpful for other families of children with autism and professionals working with ASD.
Will participants be compensated for their time or expenses?
No, there is no money in the budget allotted for compensation to families.
What risks are involved in participating in the study?
Glutathione has not been found to have any side effects, but there is the potential risk of infection or hematoma associated with IV insertion.
What safeguards are in place to minimize any risks?
The study site is the Kosair Pediatric Research Unit, which has conducted numerous such studies in the past. The nurse coordinators and phlebotomists in the research unit are highly trained.
Who should I contact if I'm interested in the study?
Carla Rich (502)629-5820
What is the duration of the study?
18 weeks; initial week of screening and signing consent; then 8 weeks of glutathione versus placebo with one week washout and then 8 weeks of the reverse protocol.