AUTISM RESEARCH STUDY
This Is A Research Study To Assess The Efficacy And Safety Of Buspirone In Young Children With Autism
What is Buspirone?
Buspirone is a medication which acts like serotonin, an important chemical involved with brain development. It is widely used to treat anxiety in adults and general anxiety disorder in children
What is the purpose of the study?
The purpose of this study is to look at whether the medication buspirone can be safely and effectively used as a new treatment for children with autism. 144 children throughout the United States ages 2-6 years who have been diagnosed with autism will take part in this study.
How do I know if my child will qualify for this study?
Some of the criteria for participation include:
- Male or Female 2-6 years of age
- Diagnosis of autism based upon DSM-IV criteria, the Autism Diagnostic Interview, and the Autism Diagnostic Observation Schedule
- Informed consent provided by parent or legal guardian
What does the study involve?
This study involves 9 visits over 24-weeks and includes random assignment to 2.5mg buspirone, 5.0mg buspirone, or placebo (no active study medication).
What will be done at the visits?
The first visit is an 8hr screening day, which involves blood work, a physical exam, psychological testing, and having the Autism Diagnostic Observation Schedule and Autism Diagnostic Interview.
The second visit is a 3hr day in which the child will have a PET (Positron Emission Tomography) scan.
The remaining 7 visits will last 2-3hrs and will include dispensing of the study medication, measuring of the child’s vital signs, and questions about how the child has been feeling
Follow-up study
There is also a follow-up portion of the study which allows children who participated in the first portion to receive active study medication for 24-weeks, and involves 7 visits
Will I have to pay for this treatment?
There is no cost to you for your child’s participation in this study.
Where will this study take place?
The study will take place at Children’s Hospital of Michigan on the 3rd floor, General Clinical Research Center.
Who is conducting this study?
Dr. Diane Chugani, Division of Neurology, Children’s Hospital of Michigan
How will I get more Information about this study?
To obtain more information, please contact:
Jamie Katusin Study Coordinator
Children’s Hospital of Michigan
jkatusin@med.wayne.edu
313-745-0148