In a first-of-its-kind decision, the FDA has approved a video game as a prescribed treatment for children with ADHD.
The FDA recently made a precedent-setting decision—for the first time, a video game can be marketed and prescribed as a therapeutic.
EndeavorRx, a digital therapeutic created by Akili Interactive Labs, is a video game designed to improve attention in children ages 8 to 12 who have been diagnosed with attention defecit hyperactivity disorder (ADHD). The DCRI’s Digital Health Solutions group, which works closely with technology companies seeking evidence to evaluate the safety and efficacy of their digital health solutions, partnered with Akili to conduct two randomized clinical trials to evaluate EndeavorRx as an effective treatment for ADHD. The DCRI is a part of the Duke University School of Medicine.
“FDA approval for this device means that we now can expand treatment options for a large group of patients who experience attention deficits,” said the DCRI’s Scott Kollins, PhD, Professor in Psychiatry and Behavioral Sciences at Duke. Kollins provided oversight for the Akili trials and co-directs the DCRI’s Digital Health Solutions group. “Akili recognized early on that clinical evidence was needed to demonstrate both the safety and efficacy of its innovative approach. Their decision to conduct randomized clinical trials demonstrates their commitment to patients and families who now can be fully confident in using EndeavorRx to treat attention disorders, either as a sole treatment or in conjunction with other medications.”
In 2017, results from a pivotal trial led by the DCRI demonstrated that Akili’s video game was safe, with only minor side effects of headaches and frustration. The results also suggested that the Akili game was effective, as children who played it tested significantly better on an FDA-cleared test designed to measure attention and impulse control when compared to a control group. Results from this study were published in The Lancet: Digital Health. In a second trial, results showed that the Akili video game was effective whether administered in conjunction with ADHD medication or as a sole therapeutic.
“As we reimagine new models of research, working with innovators to generate clinical evidence for digital health solutions will be front and center,” said DCRI Executive Director Adrian Hernandez, MD, MHS. “One goal all researchers can strive for is to make research frictionless and even fun. This groundbreaking approach to evaluating a digital device meets those goals, while supporting the evolution of regulatory science as it works to keep pace with the rapid expansion of the digital health space.”