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A Preliminary Study on the Efficacy and Safety of a Novel Digital Therapeutic Device: A Randomized Clinical Trial in South Korean Pediatric Patients With Attention-Deficit/Hyperactivity Disorder.

2026-06-16, Psychiatry Investigation (10.30773/pi.2025.0396) (online)
Semin Oh, Sejeong Lee, Hyunwook Lee, Chul Jo, Junwon Kim, Chan-Mo Yang, Bung-Nyun Kim, and Min-Sup Shin (?)
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. As digital therapeutics (DTx) emerge as adjuncts to traditional ADHD treatment, we evaluated the efficacy and safety of a novel game-based DTx (ADAM-101) in pediatric ADHD. We hypothesized that adding ADAM-101 to pharmacotherapy would improve ADHD symptoms and attention more than pharmacotherapy alone. This study represents one of the first multicenter DTx trials conducted in South Korea.
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