Dr. Andrea Marraffino
PI and Site Director
Attention deficit hyperactivity disorder (ADHD) is a trending topic in the news, social media and the research community. It’s a condition that has been steadily on the rise and believed to affect 18% of the U.S. population – in children, adolescents and adults. Diagnoses are increasing because of expanded awareness of symptoms and better evaluation methods.[1] Healthcare professionals’ understanding, and recognition of this condition is growing but still variable at best.[2] Nuances in proper diagnosis remain misunderstood by many general practitioners.
While psychostimulants such as Ritalin and Adderall are widely considered as the first choice for medication therapy, drug developers are constantly looking for ways to improve these treatments to optimally balance the goal of providing one effective dose during the day to keep people focused on important tasks, with a timed release that doesn’t extend into the evening hours to avoid causing insomnia.
Laboratory classrooms are a recognized best practice for evaluating the effectiveness of promising new medications but are also in short supply when it comes to expertise. Andrea Marraffino, Ph.D, specialties in psychiatry, general medicine and vaccines, explains how laboratory classroom assessments work and why they are the gold standard in ADHD clinical research.
Q: Tell us about how these laboratory classroom assessments work in research practice.
Dr. Marraffino: These assessments are part of study treatment schedules that may run from six to 24 weeks and complement regular scheduled outpatient visits that involve symptom and medication checks. They often involve children between the ages of six to 12 in cohorts of 18. These assessments are operationally complex, requiring an investigator, team of raters, certified teachers (in this type of assessment) and many staff members to maintain order in a tightly structured schedule of supervised activities, math assessments, breaks and recreation that can span 15-18 hours over a weekend day.
Simulated classrooms typically begin with warm-up games, followed by series of eight to 10 math tests. The first math test takes place prior to dosing and is followed by hourly post-dose sequences. Students are observed by certified raters on their ability to follow instructions during each test, and on 20 different behaviors. Rules include standard classroom expectations of no talking, keeping feet on the floor, raising hands, etc. Assessment scores include math test results and observed behavior during the math tests. The frequency of assessments over the course of the day, in between playtime and snack breaks provides a clear indication of the duration of medication. It is critical to keep strictly-timed assessments and other activities on task to observe time points of when the medication effect starts and stops. These studies deliver conclusive results but there are enormous amounts of data to be collected in a short window of time and extensive training is required for these studies to run smoothly.
Q: Are these study types commonly conducted?
Dr. Marraffino: Classroom assessments are required by the Food and Drug Administration as part of a Phase III pivotal study. COVID disruptions slowed the frequency for a few years, but the current activity is increasing, nearing pre-COVID levels. In Maitland, FL, we have several ongoing studies of this type at any given time. There are approximately five sites who conduct this type of research and ours is the most tenured site, with a long history of experience dating back to the early 2000s.
Q: What does the current pipeline for ADHD treatments look like?
Dr. Marraffino: There is always a robust pipeline for ADHD treatments. Psychostimulants work well, but many studies are conducted to continually optimize the dose and minimize common side effects. Many novel treatments are studying the effectiveness of natural supplements such as magnesium vs. conventional pharmaceutical agents.
Q: What professional advice do you have for people seeking more information, diagnosis or treatment?
Dr. Marraffino: There are still many misconceptions about ADHD. The stereotypical image tends to center on kids doing cartwheels impulsively. It presents and looks different in each patient, and so do responses to treatment. It’s also highly genetic, so for every diagnosis, there’s a good chance of a parent also having it.
Once diagnosed, most people don’t grow out of this condition, so strategies for managing the core traits are essential, whether through behavioral therapy, neurofeedback or other emerging techniques.
Psychostimulants often work well for those with hyperactivity, while alternative mechanisms of action involving vitamin supplements or non-pharmacologic digital treatments are promising for those with inattention challenges.
Clinical trials are a great way to explore treatment, but the classroom assessment isn’t for every level of diagnosis; only for those who have moderate to severe cases. At Alcanza, we take a comprehensive approach to evaluation and are extra cautious with diagnosis.
[1] https://www.health.com/why-are-more-people-getting-diagnosed-with-adhd-7112137#:
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6675769/
