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Photo by Shironosov

Digital treatment of ADHD gets FDA clearance

The first prescription treatment for children with ADHD, that's delivered through a video game, was cleared as a prescription treatment by the US Food and Drug Administration (FDA) earlier this month.

Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD in more than 85% of children diagnosed and can significantly impact daily functioning. 

“The impact of inattentiveness on functioning in children with ADHD is apparent to me on a daily basis in my practice. It affects making and keeping friends, completing tasks, building confidence and succeeding in school... My hope is that this intervention could play a valuable role as part of an integrated and comprehensive treatment approach for children with attentional challenges,” said Raun Melmed, M.D., behavioral pediatrician and director of Melmed Center, Scottsdale, Arizona. 

Driven by the core belief at Akili that effective medicine can also be fun and engaging, ENDEAVOR is delivered through an action video game experience. Using ENDEAVOR, patients navigate a character through different worlds while avoiding obstacles and collecting targets to unlock new worlds and receive awards. The captivating experience of ENDEAVOR is designed to drive engagement and compliance.    

This digital treatment has been shown in a rigorously designed and conducted clinical research program to improve attention function, as measured by computer-based testing, in children ages 8-12 years old with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. 

​EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning. The technology implements algorithms that adapt in both real-time and between treatment sessions to automatically adjust the difficulty level for a treatment experience that is personalised to the needs of each individual patient. This enables second by second monitoring of patient progress completing the treatment sessions, and continuously challenges each patient to an optimized level, encouraging patients to improve their performance.  

Shown to improve attention function, EndeavorRx is backed by data from five clinical studies, including a prospective, randomized controlled trial. These trials included more than 600 children diagnosed with ADHD. In the pivotal study, ENDEAVOR showed a statistically significant improvement compared to an educational-style video game control (p=0.006).

Also available with this treatment is the ADHD InsightTM companion app, designed to help parents track and better understand changes in their child’s behavior over time. 

​Find out more about Akili Interactive.

ADHD on NZH: Kiwis with ADHD say health response 'out of date'
ADHD on NZH: Kiwis with ADHD say health response 'out of date'
Digital medicine tool for children with ASD and co-occurring ADHD
Digital medicine tool for children with ASD and co-occurring ADHD
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