Journal of child and adolescent psychopharmacology · 2026
Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wilens Timothy E, Oberdhan Dorothee, Jin Na, Skubiak Taisa, Childress Ann C, van Stralen Judy, Ward Caroline L
Аннотация
OBJECTIVE: The objective of these analyses was to evaluate the efficacy of centanafadine for treatment of attention-deficit/hyperactivity disorder (ADHD) associated features of executive functioning and learning problems measured over 6 weeks in children and adolescents with ADHD.
METHODS: Two phase 3, randomized, double-blind, placebo-controlled trials were conducted in children and adolescents with a primary diagnosis of ADHD at sites in the United States and Canada. Data presented here are from the total population of children aged 6-12 years (NCT05428033) or adolescents aged 13-17 years (NCT05257265) who received high-dose centanafadine or placebo for 6 weeks. Secondary and other efficacy endpoints assessed change from baseline in the Conners 3-Parent Short Executive Functioning and Learning Problems Content Scale T-scores and the Conners 3-Self-report Short Learning Problems Content Scale T-scores, all analyzed using a mixed-effect model for repeated measures. Clinically meaningful within-patient change and findings from a caregiver and/or adolescent self-report exit survey are also presented.
RESULTS: Overall, 76.5% (367/480) of children (mean age 9.2 years, 41.7% female) and 80.8% (371/459) of adolescents (mean age 14.7 years, 40.7% female) completed their respective studies. There were clinically significant improvements with centanafadine treatment observed as early as Week 1 in the Conners 3-Parent Short Executive Functioning (T-score least squares mean change from baseline [standard error] to Week 6: children, -6.8 [1.1] vs. -11.3 [1.1], p = 0.0026 and adolescents, -8.1 [1.0] vs. -13.0 [1.0], p = 0.0003) and Learning Problems content scale T-scores when compared to placebo (children, -8.2 [1.0] vs. -2.8 [0.9], p < 0.0001 and adolescents, -8.0 [0.9] vs. -3.1 [0.9], p < 0.0001). Similar changes from baseline were observed by adolescent self-report (-6.1 [0.9] vs. -2.5 [0.9], p = 0.0023). Compared to placebo, there was a 50% and 88% greater chance of experiencing clinically meaningful within-patient change in executive functioning for children and adolescents, respectively, and a 79% and 81% chance for experiencing clinically meaningful within-patient change in learning problems, respectively. Exit survey data support findings from clinical outcome measures.
CONCLUSIONS: In addition to its impact on the core symptoms of ADHD, centanafadine improved executive functioning, learning problems, and impact on daily tasks in children and adolescents with ADHD.
METHODS: Two phase 3, randomized, double-blind, placebo-controlled trials were conducted in children and adolescents with a primary diagnosis of ADHD at sites in the United States and Canada. Data presented here are from the total population of children aged 6-12 years (NCT05428033) or adolescents aged 13-17 years (NCT05257265) who received high-dose centanafadine or placebo for 6 weeks. Secondary and other efficacy endpoints assessed change from baseline in the Conners 3-Parent Short Executive Functioning and Learning Problems Content Scale T-scores and the Conners 3-Self-report Short Learning Problems Content Scale T-scores, all analyzed using a mixed-effect model for repeated measures. Clinically meaningful within-patient change and findings from a caregiver and/or adolescent self-report exit survey are also presented.
RESULTS: Overall, 76.5% (367/480) of children (mean age 9.2 years, 41.7% female) and 80.8% (371/459) of adolescents (mean age 14.7 years, 40.7% female) completed their respective studies. There were clinically significant improvements with centanafadine treatment observed as early as Week 1 in the Conners 3-Parent Short Executive Functioning (T-score least squares mean change from baseline [standard error] to Week 6: children, -6.8 [1.1] vs. -11.3 [1.1], p = 0.0026 and adolescents, -8.1 [1.0] vs. -13.0 [1.0], p = 0.0003) and Learning Problems content scale T-scores when compared to placebo (children, -8.2 [1.0] vs. -2.8 [0.9], p < 0.0001 and adolescents, -8.0 [0.9] vs. -3.1 [0.9], p < 0.0001). Similar changes from baseline were observed by adolescent self-report (-6.1 [0.9] vs. -2.5 [0.9], p = 0.0023). Compared to placebo, there was a 50% and 88% greater chance of experiencing clinically meaningful within-patient change in executive functioning for children and adolescents, respectively, and a 79% and 81% chance for experiencing clinically meaningful within-patient change in learning problems, respectively. Exit survey data support findings from clinical outcome measures.
CONCLUSIONS: In addition to its impact on the core symptoms of ADHD, centanafadine improved executive functioning, learning problems, and impact on daily tasks in children and adolescents with ADHD.