FDA Has Approved the First Video Game as a Treatment for ADHD

For the very first time, the FDA has greenlit a prescription-only game-based digital therapeutic device that could help children with ADHD.

Video games are powerful, there are no two ways about it. Despite some outlets of the media world heavily dogpiling on the supposed negative effects that video games can produce on the mind, namely, their potential harm related to violence, addiction, and depression, but more recent studies over the years show how the positive aspects of playing games can improve our mental health and also our general well-being. This is why this landmark decision from the Food and Drug Administration (FDA) is such a monumental moment in showing how video games are being used in a positive light and for the treatment in ADHD for the very first time in history.

In the past, hearing about a video game that has the potential to help to manage a mental health disorder sounds wildly futuristic and almost impossible to imagine. It was widely believed that anyone who sits in front of a screen to play something as meaningless as a video game was seen as wasting their life and not a constructive use of time but thankfully, times are changing and we are beginning to see what a powerful outlet video games can really be. Scientists have come a long way in their development of understanding how the brain works and especially so with the progression or alleviating the symptoms of various mental illnesses with attention increasingly turned towards gaming as a genuine course of treatment.

For the very first time, the Food and Drug Administration has just greenlit a prescription-only “game-based digital therapeutic device,” which will allow doctors to prescribe the iPhone and iPad game called EndeavorRX for kids aged between eight and 12 years old with ADHD. Developed by American company Akili Interactive, their hope is to completely change how video games are viewed in the medical field by using this game as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which will further address symptoms of the disorder.

The decision by the FDA was based upon multiple studies in more than 600 children including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools. There were no serious adverse events reported and the most common adverse events observed with EndeavorRx like headaches and dizziness, which pale in comparison to traditional ADHD medications that can have side effects that include sleep problems. decreased appetite, weight loss, and many others.

“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”

EndeavorRX is a simple game in design in which players control a floating speeder that jumps between obstacles to get to the end of each level. The idea of this type of video game is that even though it’s not as complex in scale as to what many gamers are used to, its main goal is used to help hold the attention and focus of children who suffer from ADHD and hopefully help to reduce the symptoms associated with it.

However, it is also noted that a video game should not “be used as an alternative to established and recommended treatments for ADHD.” and also “future research is needed for this digital intervention, this study provides evidence that AKL-T01 might be used to improve objectively measured inattention in paediatric patients with ADHD, while presenting minimal adverse events.”

The next step for EndeavorRX is to launch the game. An Akili representative told The Verge that they opened up enrollment for a limited number of families under the FDA’s relaxed COVID-19 enforcement back in April. If this all sounds like something you would be willing to participate in, you can head on over to the company’s website to get set up on a waitlist so you can join.

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Rachael Fiddis

Rachael, who is Deputy Editor, has been gaming for many years. Some of her favourite video games include The Witcher 3 and The Last of Us but also loves a good indie title. Gaming Culture is where her heart lies and spends many hours sieving through gaming fan art and cosplay displays. Other than gaming, Rachael is a book nerd and music lover.

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