Abstracts
3427205
(#7) Emotional Dysregulation Symptom Outcomes in Adults With ADHD Treated with Centanafadine: A Pooled Post hoc Analysis of Two Phase 3 Trials
Abstract: Introduction: ADHD in adults frequently includes symptoms of emotional dysregulation, such as affective lability, emotional overreactivity, frustration tolerance, and anger outbursts. 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 emotional dysregulation using the adult ADHD Self-Report Scale (ASRS) Expanded Version after 6 weeks of treatment in adults with ADHD.
Methods: Eligible patients (aged 18-55y) 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 Emotional Dyscontrol (ED) subscale and individual ED items 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 from baseline vs placebo on the ASRS ED subscale, reflecting reduced frequency of specific patient-reported emotional dysregulation dimensions assessed by the scale (200mg, P 0.01; 400mg, P 0.001). Effect sizes were 0.27 for 200mg and 0.31 for 400mg. Consistent with the subscale-level findings, improvements vs placebo were also observed across individual ED items, including those related to affective lability, emotional overreactivity, and anger outbursts.
Conclusions: Centanafadine was associated with improvements in patient-reported emotional dysregulation in adults with ADHD, as assessed by the ASRS Expanded Version. Improvements were observed across ED items capturing behavioral dimensions of emotional dysregulation, including affective lability, emotional overreactivity, and anger outbursts, with effects of similar magnitude to those observed for core ADHD symptom 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 emotional dysregulation using the ASRS Expanded Version after 6 weeks of treatment in adults. Compared to placebo, centanafadine was associated with greater improvements in emotional dysregulation, including affective lability, emotional overreactivity, and anger outbursts, with effects of similar magnitude to those observed for core ADHD symptom domains.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
Methods: Eligible patients (aged 18-55y) 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 Emotional Dyscontrol (ED) subscale and individual ED items 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 from baseline vs placebo on the ASRS ED subscale, reflecting reduced frequency of specific patient-reported emotional dysregulation dimensions assessed by the scale (200mg, P 0.01; 400mg, P 0.001). Effect sizes were 0.27 for 200mg and 0.31 for 400mg. Consistent with the subscale-level findings, improvements vs placebo were also observed across individual ED items, including those related to affective lability, emotional overreactivity, and anger outbursts.
Conclusions: Centanafadine was associated with improvements in patient-reported emotional dysregulation in adults with ADHD, as assessed by the ASRS Expanded Version. Improvements were observed across ED items capturing behavioral dimensions of emotional dysregulation, including affective lability, emotional overreactivity, and anger outbursts, with effects of similar magnitude to those observed for core ADHD symptom 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 emotional dysregulation using the ASRS Expanded Version after 6 weeks of treatment in adults. Compared to placebo, centanafadine was associated with greater improvements in emotional dysregulation, including affective lability, emotional overreactivity, and anger outbursts, with effects of similar magnitude to those observed for core ADHD symptom domains.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
