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Poster 142

(#142) Efficacy of Centanafadine on Conners 3 Content Scales in Adolescents with Attention-Deficit/Hyperactivity Disorder

Caroline Ward - Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, United States; Dorothee Oberdhan - Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, United States; Na Jin - Otsuka Pharmaceutical Development & Commercialization, Inc.; Taisa Skubiak - Otsuka Pharmaceutical Development & Commercialization Inc.; Judy van Stralen - Center for Pediatric Excellence, Ottawa, ON, Canada; Ann Childress - Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA
Psych Congress 2025
Abstract: Hypothesis/Objective: This study evaluates the treatment impact of centanafadine (CTN), a norepinephrine, dopamine, serotonin reuptake inhibitor, on hyperactivity/impulsivity (H/I), inattention, and executive functioning (EF) symptoms via caregiver- and/or self-report in adolescents with ADHD.

Methods: A phase 3 trial evaluated efficacy and safety of once-daily extended-release CTN for ADHD treatment in adolescents (N=451; aged 13-17y). Participants received CTN 328.8 mg, 164.4 mg, or placebo for 6 weeks. Additional efficacy outcomes were the Conners 3-Parent Short (PS; caregiver perspective) and Conners 3-Self-Report Short (Conners 3-SRS) H/I, inattention, and EF content scale T-scores at Week 6. Values are LS mean change from baseline (standard error) and were analyzed using a mixed-effect model for repeated measures. P-values were not controlled for multiplicity.

Results: Improvements in H/I were observed for CTN 328.8 mg vs placebo on Conners 3-PS (−14.0 [1.1] vs −8.5 [1.1], P=0.0002) and Conners 3-SRS (−11.6 [0.9] vs −8.9 [0.9], P=0.0282). Improvements in inattention were observed per Conners 3-PS for CTN 328.8 mg vs placebo (−14.4 [1.0] vs −8.1 [1.0], P 0.0001) and Conners 3-SRS (−15.3 [1.1] vs −10.0 [1.0], P=0.0001). Similarly, improvements in EF were observed for CTN 328.8 mg vs placebo on Conners 3-PS (−13.0 [1.0] vs −8.1 [1.0], P=0.0003); Conners 3-SRS was not utilized for the EF content scale.

Conclusions: CTN 328.8 mg showed improvements in H/I, inattention, and EF symptoms in adolescent participants when compared to placebo, with both greater caregiver and adolescent 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, adolescents with ADHD treated with CTN showed improvements in inattention, hyperactivity/impulsivity, and executive functioning with both greater caregiver and adolescent perceptions of symptom improvement.

Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.