Poster
143
(#143) Efficacy of Centanafadine on Conners 3 Content Scales in Children with Attention-Deficit/Hyperactivity Disorder
Psych Congress 2025
Abstract: Hypothesis/Objective: The aim of this work was to evaluate the impact of centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor under investigation for ADHD treatment-on hyperactivity/impulsivity (H/I), inattention, and executive functioning (EF) via caregiver-report in children with ADHD.
Methods: This phase 3, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment in children (aged 6-12y). Participants were randomized (1:1:1) to weight-based high-dose CTN, low-dose CTN, or placebo for 6 weeks. Secondary efficacy outcomes included the Conners 3-Parent Short (PS; caregiver perspective) H/I, inattention, and EF content scale T-scores at Week 6, analyzed using a mixed-effect model for repeated measures. Values are LS mean change from baseline (standard error). P-values were not controlled for multiplicity.
Results: Overall, 457 children were randomized and treated. Significant improvements in H/I were observed for high-dose CTN vs placebo on the Conners 3-PS at Week 6 (−11.5 [1.1] vs −6.9 [1.1], P=0.0022). Similarly, significant improvements were also seen in other content scales at Week 6 (inattention: −11.9 [1.1] vs −6.4 [1.1], P=0.0002; EF: -11.3 [1.1] vs -6.8 [1.1], P=0.0026).
Conclusions: High-dose CTN showed an early and sustained impact on improving core H/I, inattention, and executive functioning symptoms of ADHD in children when compared to placebo, with greater caregiver perceptions of symptom improvement.
Short Description: ADHD is one of the most common pediatric neurodevelopmental disorders, characterized by symptoms of inattention, hyperactivity, and impulsivity. Centanafadine (CTN) is a norepinephrine, dopamine, and serotonin reuptake inhibitor under investigation for the treatment of ADHD in pediatric and adult patients. In this study, CTN showed an early and sustained impact on improving core and executive functioning symptoms of ADHD in children when compared to placebo, with greater caregiver perceptions of symptom improvement.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
Methods: This phase 3, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment in children (aged 6-12y). Participants were randomized (1:1:1) to weight-based high-dose CTN, low-dose CTN, or placebo for 6 weeks. Secondary efficacy outcomes included the Conners 3-Parent Short (PS; caregiver perspective) H/I, inattention, and EF content scale T-scores at Week 6, analyzed using a mixed-effect model for repeated measures. Values are LS mean change from baseline (standard error). P-values were not controlled for multiplicity.
Results: Overall, 457 children were randomized and treated. Significant improvements in H/I were observed for high-dose CTN vs placebo on the Conners 3-PS at Week 6 (−11.5 [1.1] vs −6.9 [1.1], P=0.0022). Similarly, significant improvements were also seen in other content scales at Week 6 (inattention: −11.9 [1.1] vs −6.4 [1.1], P=0.0002; EF: -11.3 [1.1] vs -6.8 [1.1], P=0.0026).
Conclusions: High-dose CTN showed an early and sustained impact on improving core H/I, inattention, and executive functioning symptoms of ADHD in children when compared to placebo, with greater caregiver perceptions of symptom improvement.
Short Description: ADHD is one of the most common pediatric neurodevelopmental disorders, characterized by symptoms of inattention, hyperactivity, and impulsivity. Centanafadine (CTN) is a norepinephrine, dopamine, and serotonin reuptake inhibitor under investigation for the treatment of ADHD in pediatric and adult patients. In this study, CTN showed an early and sustained impact on improving core and executive functioning symptoms of ADHD in children when compared to placebo, with greater caregiver perceptions of symptom improvement.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
