Autism, Asperger’s Disorder and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) are brain development disorders that affect social interaction, communication and behavior at varying degrees of severity.
The symptoms of these autistic disorders are often managed with therapies, such as behavioral therapy and with some medications to alleviate symptoms such as anxiety or depression.
There are approved drugs to treat the irritability associated with autistic disorder; however, there are currently no drugs approved for the treatment of the core symptoms of autism. Furthermore, there are currently no approved drug therapies for Asperger’s Disorder or PDD-NOS. There is a drastic need for research to both identify causes and better treat these conditions.
A study called ConnectMe-91is actively seeking participants of all races and ethnicities. CAMC is the only site in West Virginia participating in the trial.
The goal of the ConnectMe program is to evaluate the safety, tolerability and effectiveness of an investigational drug on social interaction and communication skills in patients aged 6 to 12 with autism, Asperger’s Disorder and PDD-NOS.
The symptoms usually show up between 2 and 3 years of age. What researchers learn from this clinical research may help to develop treatment options for children with these conditions in the future.
There are two related studies to this trial for eligible participants.
The prevalence of these disorders is increasing rapidly, yet the cause of such disorders is unknown. A report issued by the CDC in April 2012 shows that as many as 1 in 88 children, and 1 in 54 boys and 1 in 252 girls, in the United States has an autism spectrum disorder (http://www.cdc.gov/media/releases/2012/p0329_autism_disorder.html).
Clinical research trials are medical- or health-related research studies conducted with people who volunteer to participate. Clinical studies are conducted not only to determine the potential safety and effectiveness of new investigational drugs, but also to test existing, approved drugs for use in treating a different medical condition. An investigational drug is one that is not yet approved for the treatment of the intended medical condition and is therefore not approved for sale or distribution to the wider public.