Poster
144
(#144) Impact of Centanafadine on Executive Functioning in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder: Analysis of Conners 3 and Exit Survey Responses
Psych Congress 2025
Abstract: Hypothesis/Objective: To compare the executive functioning (EF) efficacy measure with patient exit interviews in children and adolescents treated for ADHD with centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor.
Methods: Two phase 3 trials evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment (aged 6-12y and 13-17y, respectively). Participants were randomized (1:1:1) to high-dose CTN, low-dose CTN, or placebo (children received weight-based CTN) for 6 weeks. A key secondary efficacy endpoint was the change from baseline in Conners 3-Parent Short EF content scale (containing 5 individual line items) T-score at Week 6, analyzed via a mixed-effect model for repeated measures. Exit survey values reflect those who selected either "somewhat better" or "much better." All data here are caregiver-reported.
Results: Mean baseline EF T-scores were 74.3 in adolescents and 78.6 in children. In participants treated with high-dose CTN, a greater number of adolescents (48% vs 26%; P=0.0002) and children (40% vs 26%; P=0.0163) had a clinically meaningful change (≥13-point reduction) in EF T-scores versus placebo. Per the caregiver-reported exit survey, of those treated with high-dose CTN, 69% (vs 45% placebo) of adolescents and 52% (vs 38% placebo) of children saw improvement in completing tasks at home. Similarly, 64% (vs 44% placebo) of adolescents and 50% (vs 38% placebo) of children saw improvement in completing work at school.
Conclusions: Consistent with clinically meaningful change in EF, for children and adolescents treated with CTN, caregiver-reported perceptions of completing tasks at home and school showed improvement when compared to placebo.
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, clinically meaningful change in executive function was observed for children and adolescents treated with CTN. Similarly, caregiver-reported perceptions of completing tasks at home and school showed improvement.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
Methods: Two phase 3 trials evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment (aged 6-12y and 13-17y, respectively). Participants were randomized (1:1:1) to high-dose CTN, low-dose CTN, or placebo (children received weight-based CTN) for 6 weeks. A key secondary efficacy endpoint was the change from baseline in Conners 3-Parent Short EF content scale (containing 5 individual line items) T-score at Week 6, analyzed via a mixed-effect model for repeated measures. Exit survey values reflect those who selected either "somewhat better" or "much better." All data here are caregiver-reported.
Results: Mean baseline EF T-scores were 74.3 in adolescents and 78.6 in children. In participants treated with high-dose CTN, a greater number of adolescents (48% vs 26%; P=0.0002) and children (40% vs 26%; P=0.0163) had a clinically meaningful change (≥13-point reduction) in EF T-scores versus placebo. Per the caregiver-reported exit survey, of those treated with high-dose CTN, 69% (vs 45% placebo) of adolescents and 52% (vs 38% placebo) of children saw improvement in completing tasks at home. Similarly, 64% (vs 44% placebo) of adolescents and 50% (vs 38% placebo) of children saw improvement in completing work at school.
Conclusions: Consistent with clinically meaningful change in EF, for children and adolescents treated with CTN, caregiver-reported perceptions of completing tasks at home and school showed improvement when compared to placebo.
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, clinically meaningful change in executive function was observed for children and adolescents treated with CTN. Similarly, caregiver-reported perceptions of completing tasks at home and school showed improvement.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
