Expired Study
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Clinical Trial 14228

New Haven, CT 06510

Study Summary:

This study, funded by the National Institute of Mental Health (NIMH) and Shire Pharmaceuticals, will be conducted by the Research Units in Pediatric Psychopharmacology (RUPP) Autism Network at four sites across the country (Indiana University (IU), the University of California at Los Angeles (UCLA), Seattle Children’s Research Institute (University of Washington) and Yale University).

The purpose of the study is to evaluate the effectiveness of extended release guanfacine (ERG) in reducing hyperactivity and impulsiveness in children with PDD.

As part of this study, your child will undergo a variety of assessments including but not limited to medical history, intelligence and cognitive battery.

You will be randomly assigned (i.e. by chance) to either an active drug (guanfacine) or placebo control treatment group. In both treatments, you will be placed in an 8 week program of increasing dosage with weekly visits for the first month and biweekly visits during the 2nd month.

Medication will be carefully monitored throughout the entire program. Based upon treatment response after the 8 week treatment period, subjects will have the option of continuing the current treatment for another 8 weeks, participating in a methylphenidate (MPH) 4 week add-on trial, or for those in the placebo group, an 8 week trial of guanfacine.

Qualified Participants Must:

• Be between ages 5 and 14
• Weigh at least 15kg (33lbs)
• Have a diagnosis of PDD (Autistic Disorder, Asperger’s Disorder, or PDD-NOS) with clinically significant hyperactivity
• Be medication free or currently on an ineffective medication that can be tapered prior to study entry (confirmed by clinical assessment)

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.