Alcanza Clinical Research

According to the CDC, more than 6 million children are estimated to have ever been diagnosed with attention-deficit/hyperactivity disorder (ADHD) in the U.S.

But the road to that diagnosis is not always a straight one. Oftentimes, parents and children have to wait for a year or longer to receive an ADHD diagnosis, all the while delaying treatment and verification for school and creating stress for all involved.

Clinical trials can be a vital lifeboat for some in this situation. Trials mean doctors—like Principal Investigator Dr. Andrea Marraffino at Accel Research Sites—can cut through the red tape and not only help parents and children get that diagnosis quickly, but help in general.

During the pandemic, many clinical trials that were not focused on the COVID-19 vaccine were put on the back burner. Now, Dr. Marraffino and her team are ready to get back to work helping children and families affected by ADHD.

Accel Research Sites has a number of important ADHD trials starting in the next few weeks and months—including innovative trials involving gamification and those aimed at preschoolers and teenagers.

Purdue Pharma

The first study, with Purdue Pharma, is looking for children ages 4 to 12 diagnosed with ADHD or who show symptoms of ADHD. The clinical trial will be testing a treatment in children that is already FDA approved for patients 6 years and older. Clinical trial participants will be provided study medication to take once every morning while enrolled. Participation in the trial will last up to 12 months and includes up to 20 in-person visits. The trial is not placebo-controlled, meaning no enrolled participants will receive a placebo drug. Everyone enrolled will receive active study medication. Candidates do not need a previous diagnosis of ADHD.

Akili Interactive

The second study involves digital therapy in adolescents ages 12 to 17. Through a gaming treatment with Akili Interactive that targets areas of the brain that affect attention, participants learn skills that can help them with prioritizing tasks, ignoring distractions and multitasking. Participation in the clinical trial lasts up to three months and will allow participants to be seen once a month by professionals. Candidates do not need a previous diagnosis of ADHD and can continue current medication treatment for ADHD. Akili Interactive’s treatment is already approved by the FDA for children ages 8 to 12 and was the first treatment option delivered through a video game experience approved by the FDA.

“Our trials offer help to those parents frustrated by restrictions and who need verification of a diagnosis for school systems,” Dr. Marraffino said. “Our clinical trials allow patients to be evaluated, diagnosed and treated in a fraction of the time it typically can take. Our focus is on the patients and giving parents peace of mind.”

Before studies begin, participants will meet with investigators for a full evaluation and diagnostic assessments. Medication studies also include physical exams, blood tests and EKGs throughout the course of the study. All study procedures and study medication are provided to participants at no cost. Enrolled participants will be compensated for their time in the trial.