Video game as therapy: FDA makes landmark ADHD approval

The US Food and Drugs Administration (FDA) has approved a video game as a treatment for attention deficit hyperactive disorder (ADHD) after it proved effective in trials.

The treatment is licensed for patients aged between eight and twelve years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Known as EndeavorRxTM (AKL-T01), the game is manufactured by Akili Interactive Labs.

The software monitors and adapts to the patient playing the game, and “continuously challenges each patient to an optimised level, encouraging patients to improve their performance”.

The FDA’s De Novo pathway was used to assess the treatment. Its approval could launch a whole new class of therapies into the options clinicians can consider for their patients.

Elysa Marco, cognitive and behavioural child neurologist said:

“For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school… Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention. Based on the benefits my research participants and patients have experienced, I am thrilled that EndeavorRx is moving from the lab to the clinic to play an essential role as part of a comprehensive treatment plan for children with ADHD.”

Akili explained the scientific evidence showing the game’s efficacy:

“EndeavorRx was granted clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomised, controlled study… which showed EndeavorRx improved objective measures of attention in children with ADHD. After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx…”

Read Akili’s announcement here.

Tagged with

Published on 18. June 2020 in News