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 in 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). One of the visits involves an overnight/ 2 day trip to Detroit for a PET scan for you and your child if you choose to.
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
During the second visit your child can have a PET (Positron Emission Tomography) scan. It is a 3 hour day, but all PET scans for the study are done in Detroit at Children s Hospital of Michigan.
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 NYU Child Study Center
Who is conducting this study
Dr. Ruth Nass
NYU Medical Center
In collaboration with several other medical centers across the country funded by an NIH grant.
How will I get more information about this study
To obtain more information please contact:
Amira Hanna
Study Coordinator
NYU Child Study Center
(212) 263-7753
