Study Information: Pediatric ADHD
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood, and often lasts into adulthood.
Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. This clinical trial focuses on children with ADHD who are exhibiting impulsive or aggressive behaviors, and who are currently taking medication for the disorder.
If your child – or the child of a relative or friend – fits this description, please read further and consider contacting us, or informing others who might be interested.
This clinical trial is sponsored by Supernus Pharmaceuticals.
The study is being conducted to see if an investigational medication (study drug) will improve behavior in children who are already taking an existing, approved ADHD medicine. The investigational medication has been approved for the treatment of other neuropsychiatric disorders; the study will help determine if it is safe and effective when used to treat ADHD.
The study is placebo-controlled, which means that some participants will receive the study drug while others, randomly assigned, will get a placebo, which contains no medication. Neither the study team, nor participants, parents or caretakers, know which children are taking the investigational medication and which are taking the placebo.
Dr. Sarah Atkinson is the principal investigator (PI) for this study. She is a board certified psychiatrist with over twenty years’ experience in the field of central nervous system disorders in children and adults.
How is the study conducted?
Participants will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) seven times over a period of about 12 weeks. In the first part of the trial, Dr. Atkinson will discuss the study with you (parent or caretaker) to determine if this study is appropriate for the child. If the child joins the trial, he or she will begin taking either the study medication or placebo. The child will continue taking his or her prescribed ADHD medication during the study.
There is no cost to participate, and no insurance is required. Study participants are paid a stipend for time and travel for each visit.
Does your child – or a child you’re concerned about – qualify for this clinical trial?
Every clinical study requires that participants meet certain criteria. Dr. Atkinson will make a medical determination as to whether he or she is able to participate in the study, but you can get a quick idea of whether or not a child may qualify by answering these four questions: