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First Ever Prescription Video Game Gains FDA Clearance for ADHD Treatment

First Ever Prescription Video Game Gains FDA Clearance for ADHD Treatment

Children with problems concentrating tend to gravitate towards video games, a cause for concern among many parents, even though  no evidence supports the notion that video games contribute to  Attention Deficit / Hyperactivity Disorder (ADHD). In fact, new medical developments suggest the opposite is true. 

Last month, a prescription video game treatment for ADHD received clearance from the U.S. Food and Drug Administration (FDA), marking the creation of a new class of digital therapeutics. The move potentially opens the door for video game and virtual reality treatments to become more commonplace for a range of conditions and disorders.

The game, called EndeavorRx, was developed by Akili Interactive, a digital medicine company based in Boston and San Francisco. In a press release, Akili Chief Executive Officer Eddie Martucci described the product as “a first-of-its-kind non-drug treatment option.” Unlike ADHD medication, EndeavorRx specifically targets attention function in young children, aiming to help them focus and resist distraction. Akili Senior Vice President of Medical Devices Scott Kellogg said in the press release that the FDA clearance of the game challenges “the status quo of medicine.” 

EndeavorRx is an action video game with a premise that is likely to sound familiar to anyone with video game experience: The player selects an avatar, explores different realms, faces obstacles, and advances to gain access to new dimensions. However, under the surface, the game’s algorithms activate neurological systems in the brain that control attention function, and the mental training can have long-term effects. 

Data from five clinical studies of over 600 children diagnosed with ADHD was considered in the decision to grant FDA clearance to EndeavorRx. One randomized control study, published this April in The Lancet Digital Health, found that about half of parents reported a “clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx,” according to Akili Interactive’s press release. After two months, 68 percent of parents reported positive results. It also noted that the only adverse effects reported by study participants were frustration and headaches in children ages seven to nine. The study was funded by Akili Interactive. 

Dr. Scott H. Kollins, Professor in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine, was the lead researcher on the study. Says Kollins, “The clearance of an app-based treatment for kids with ADHD adds a much-needed option for specifically managing attentional issues, which lead to a wide range of academic and social impairments.” He adds that more research is needed, but describes the FDA clearance of EndeavorRx as a “critical innovation.” 

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A release date has not been announced, but once it is available EndeavorRx will require a prescription. It will come in the form of an app and won’t require any extra equipment, aside from a smart device such as a phone or computer. 

“Given its digital format, this treatment could help children and families who otherwise may have difficulty accessing evidence-based treatments,” says Kollins. 

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