Abstracts
3427207
(#6) ASRS Outcomes Across Core and Expanded Symptom Domains After 6 Weeks of Centanafadine Treatment in Adults With ADHD: A Pooled Post hoc Analysis of Two Phase 3 Trials
Abstract: Introduction: This pooled post hoc analysis of two phase 3 trials evaluated the effect of centanafadine-a norepinephrine, dopamine, serotonin reuptake inhibitor-on patient-reported assessment of the frequency of core symptoms and associated features of ADHD after 6 weeks of treatment in adults aged 18-55y.
Methods: Eligible patients with a primary ADHD diagnosis per DSM-5 were randomized to centanafadine 200 or 400mg/day or placebo. Exploratory endpoints included changes from baseline in the adult ADHD Self-Report Scale (ASRS-18) Total score and Inattention (IA) and Hyperactive/Impulsive (H/I) subscales, as well as Executive Function (EF) and Emotional Dyscontrol (ED) subscales from the ASRS Expanded Version at Week 6. Endpoints were analyzed using a mixed-effects model for repeated measure without adjusting for multiplicity.
Results: At Week 6, centanafadine demonstrated greater improvements in ADHD symptom frequency per ASRS Total score and IA and H/I subscales vs placebo (all P 0.001). Effect sizes were 0.42 and 0.45 for IA and 0.30 and 0.42 for H/I at the 200mg and 400mg doses, respectively. Consistent with the core symptom domains, improvements were observed in both the EF (both P 0.001) and ED (200mg, P 0.01; 400mg, P 0.001) subscales of the ASRS Expanded Version. For EF, effect sizes were 0.36 at 200mg and 0.38 at 400mg; for ED, effect sizes were 0.27 and 0.31, respectively.
Conclusions: Centanafadine was associated with improvements from baseline in the ASRS Total score and subscales assessing both core symptoms and associated features of ADHD, including executive dysfunction and emotional dysregulation, with similar magnitudes across domains.
Short Description: This pooled post hoc analysis of two phase 3 trials evaluated the effect of centanafadine-a norepinephrine, dopamine, serotonin reuptake inhibitor-on patient-reported assessment of the frequency of core symptoms and associated features of ADHD in adults. Compared to placebo, centanafadine was associated with greater improvements in inattention, hyperactivity, impulsivity, executive dysfunction, and emotional dysregulation on the ASRS, with effects of similar magnitude across domains.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
Methods: Eligible patients with a primary ADHD diagnosis per DSM-5 were randomized to centanafadine 200 or 400mg/day or placebo. Exploratory endpoints included changes from baseline in the adult ADHD Self-Report Scale (ASRS-18) Total score and Inattention (IA) and Hyperactive/Impulsive (H/I) subscales, as well as Executive Function (EF) and Emotional Dyscontrol (ED) subscales from the ASRS Expanded Version at Week 6. Endpoints were analyzed using a mixed-effects model for repeated measure without adjusting for multiplicity.
Results: At Week 6, centanafadine demonstrated greater improvements in ADHD symptom frequency per ASRS Total score and IA and H/I subscales vs placebo (all P 0.001). Effect sizes were 0.42 and 0.45 for IA and 0.30 and 0.42 for H/I at the 200mg and 400mg doses, respectively. Consistent with the core symptom domains, improvements were observed in both the EF (both P 0.001) and ED (200mg, P 0.01; 400mg, P 0.001) subscales of the ASRS Expanded Version. For EF, effect sizes were 0.36 at 200mg and 0.38 at 400mg; for ED, effect sizes were 0.27 and 0.31, respectively.
Conclusions: Centanafadine was associated with improvements from baseline in the ASRS Total score and subscales assessing both core symptoms and associated features of ADHD, including executive dysfunction and emotional dysregulation, with similar magnitudes across domains.
Short Description: This pooled post hoc analysis of two phase 3 trials evaluated the effect of centanafadine-a norepinephrine, dopamine, serotonin reuptake inhibitor-on patient-reported assessment of the frequency of core symptoms and associated features of ADHD in adults. Compared to placebo, centanafadine was associated with greater improvements in inattention, hyperactivity, impulsivity, executive dysfunction, and emotional dysregulation on the ASRS, with effects of similar magnitude across domains.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
