Trial reportPsychiatry and clinical neurosciences2025
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.
Trial report in Psychiatry and clinical neurosciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- 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.Psychiatry investigation · 2026Article
- Integrating single-channel EEG neurofeedback into video game-based digital therapeutics for ADHD.Journal of neuroengineering and rehabilitation · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
aimThis 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).
methodsIn 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.
resultsIn 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.
conclusionSDT-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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.