Abstracts
3427206
(#4) Executive Function 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 impairments in executive functions such as organization, planning, time management, and working memory. 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 executive functioning 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 Executive Function (EF) subscale and individual EF 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 in the ASRS EF subscale, reflecting reduced frequency of patient-reported executive functioning difficulties (both P 0.001). Effect sizes for the EF subscale were 0.36 for 200mg and 0.38 for 400mg, and were comparable to those for core symptom subscales. Consistent with subscale-level findings, improvements vs placebo were also observed across individual EF items, including those related to time management, planning and prioritization, task initiation/completion, and working memory-related difficulties.
Conclusions: Centanafadine was associated with improvements in patient-reported executive functioning in adults with ADHD, as assessed by the ASRS Expanded Version. Improvements were observed across a broad range of executive function items, including time management, planning and prioritization, task initiation/completion, and working memory-related difficulties.
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 executive functioning using the ASRS Expanded Version after 6 weeks of treatment in adults. Compared to placebo, centanafadine was associated with greater improvements in executive functioning, including time management, planning and prioritization, task initiation/completion, and working memory-related difficulties, with effects of similar magnitude to 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 Executive Function (EF) subscale and individual EF 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 in the ASRS EF subscale, reflecting reduced frequency of patient-reported executive functioning difficulties (both P 0.001). Effect sizes for the EF subscale were 0.36 for 200mg and 0.38 for 400mg, and were comparable to those for core symptom subscales. Consistent with subscale-level findings, improvements vs placebo were also observed across individual EF items, including those related to time management, planning and prioritization, task initiation/completion, and working memory-related difficulties.
Conclusions: Centanafadine was associated with improvements in patient-reported executive functioning in adults with ADHD, as assessed by the ASRS Expanded Version. Improvements were observed across a broad range of executive function items, including time management, planning and prioritization, task initiation/completion, and working memory-related difficulties.
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 executive functioning using the ASRS Expanded Version after 6 weeks of treatment in adults. Compared to placebo, centanafadine was associated with greater improvements in executive functioning, including time management, planning and prioritization, task initiation/completion, and working memory-related difficulties, with effects of similar magnitude to core ADHD symptom domains.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
