Efficacy and safety of SDT-001, a dual-task digital device, in managing attention-deficit/hyperactivity disorder symptoms in children and adolescents: a phase 3, randomized, standard treatment-controlled study.

Aim: This phase 3, multicenter, open-label study aimed to evaluate the efficacy and safety of SDT-001, a dual-task digital device, compared to standard treatment (environmental and/or psychosocial treatment: treatment as usual; TAU) in the comparison part and to evaluate the safety, tolerability, and long-term efficacy of SDT-001 in the repetition part in Japanese children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

Methods: In the comparison part, participants on standard treatment were randomized (2:1) to SDT-001 (n = 109; 25 min/day for 6 weeks, with a 4-week follow-up) or TAU (n = 55) groups. Participants (n = 126) from the comparison part transitioned to a single-arm repetition part with SDT-001 (6 weeks and followed for 12 weeks). Primary endpoint in the comparison part was changed from baseline to 6 weeks in ADHD rating scale IV (ADHD-RS-IV) inattention scores.

Results: In the comparison part, SDT-001 demonstrated superiority to TAU, with significantly greater improvements from baseline to week 6 in ADHD-RS-IV inattention (adjusted mean difference [95% confidence interval], -2.97 [-4.38, -1.56]; P < 0.0001), total (-4.56 [-6.75, -2.38]; P < 0.0001), and hyperactivity-impulsivity (-1.55 [-2.64, -0.46]; P = 0.0056) scores. Additionally, other secondary endpoints showed improvements in symptoms in the SDT-001 group. In the repetition part, SDT-001 showed sustained reductions in ADHD-RS-IV scores till 12 weeks after completion of the 6-week treatment. No new severe adverse events or safety concerns were reported.

Conclusion: SDT-001 demonstrated superior efficacy at week 6 in ADHD-RS-IV compared to TAU, and reductions in scores were maintained up to the following 12 weeks, indicating its potential as a novel digital therapeutic option for ADHD management.