Investigational Medication to be Studied in Children with Autism

Children with autism spectrum disorder between the ages of five and 17 years are needed to participate in a research study looking at how a medicine called fluoxetine works to relieve the repetitive behavior and other symptoms associated with autistic spectrum disorder (ASD). The study will take place at the John Merck Child Outpatient Clinic and Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center (UPMC).

Researchers are looking for both children with autism and those who have symptoms of ASD. For the purpose of this study, fluoxetine is investigational. An investigational drug is one which has not been approved for this use by the U.S. Food and Drug Administration (FDA).

Autism is a developmental disorder that is characterized by impairments in communication and social interaction skills, as well as the presence of stereotyped patterns of behavior. Many children with autism also experience challenging behaviors, such as overactivity, anxiety, irritability and agitation. The targeted behaviors for this study include:

* constant rocking, spinning, twirling or pacing
* repeating words or phrases over and over
* repeating activities such as going in and out of doorways, picking up and putting down objects
* insisting objects be in a precise order; or that they do things in a particular way or particular order, et cetera
* insisting parents or caregivers perform activities in the same manner over and over again
* asking the same questions or making the same requests over and over
* issues with any other type of repetitive behavior that interferes with daily function

The study will require nine visits, and additional visits may be scheduled if clinically indicated. Participants will be compensated for their time.

For more information about the study, call Sarah McAuliffe-Bellin, M.Ed., at 412-235-5447.