Poster
145
(#145) Impact of Intrinsic Factors on the Efficacy of Centanafadine in an Adult Population with Attention-Deficit/Hyperactivity Disorder
Psych Congress 2025
Abstract: Hypothesis/Objective: Attention-deficit/hyperactivity disorder (ADHD) is a chronic and prevalent neurodevelopmental disorder in adults, characterized by symptoms of inattention, hyperactivity, and impulsivity. This pooled analysis evaluated the impact of intrinsic factors on the efficacy of centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor-in adults with ADHD.
Methods: Data from 2 identically designed phase 3 trials (NCT03605680, NCT03605836) were pooled. Eligible patients aged 18-55 years with a primary ADHD diagnosis per DSM-5 were randomized to receive CTN 200 or 400mg/day or placebo. Efficacy endpoints included changes from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score and Clinical Global Impression-Severity (CGI-S) for ADHD at Week 6. Subgroups were defined by sex, race, and ethnicity. Endpoints were analyzed using a mixed-effects model for repeated measures without adjusting for multiplicity and are therefore descriptive.
Results: Of the 859 adults, 52% (n=443) were male, 80.3% (n=690) White, and 19.8% (n=170) Hispanic/Latino. Across the pooled adult population, both the male and female, White, and non-Hispanic/Latino subgroups treated with CTN 200 and 400mg demonstrated improvement in the core symptoms of ADHD per AISRS total score vs placebo (P 0.05) at Week 6. Improvements in symptom severity per the CGI-S were observed in the male, White, and the not Hispanic/Latino subgroups treated with CTN vs placebo (P 0.05). Overall, there were no significant treatment-by-subgroup interactions (P 0.05), indicating a similar effect across all subgroups.
Conclusions: CTN treatment demonstrated improvement in core ADHD symptoms and symptom severity vs placebo irrespective of sex, race, ethnicity in adults with ADHD.
Short Description: This pooled analysis of two phase 3 trials assessed the impact of intrinsic factors on centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor-efficacy in adults with ADHD. CTN significantly improved core ADHD symptoms and severity versus placebo across sec, race, and ethnicity subgroups at Week 6. No significant treatment-by-subgroup interactions were observed, indicating consistent efficacy across populations.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc.
Methods: Data from 2 identically designed phase 3 trials (NCT03605680, NCT03605836) were pooled. Eligible patients aged 18-55 years with a primary ADHD diagnosis per DSM-5 were randomized to receive CTN 200 or 400mg/day or placebo. Efficacy endpoints included changes from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score and Clinical Global Impression-Severity (CGI-S) for ADHD at Week 6. Subgroups were defined by sex, race, and ethnicity. Endpoints were analyzed using a mixed-effects model for repeated measures without adjusting for multiplicity and are therefore descriptive.
Results: Of the 859 adults, 52% (n=443) were male, 80.3% (n=690) White, and 19.8% (n=170) Hispanic/Latino. Across the pooled adult population, both the male and female, White, and non-Hispanic/Latino subgroups treated with CTN 200 and 400mg demonstrated improvement in the core symptoms of ADHD per AISRS total score vs placebo (P 0.05) at Week 6. Improvements in symptom severity per the CGI-S were observed in the male, White, and the not Hispanic/Latino subgroups treated with CTN vs placebo (P 0.05). Overall, there were no significant treatment-by-subgroup interactions (P 0.05), indicating a similar effect across all subgroups.
Conclusions: CTN treatment demonstrated improvement in core ADHD symptoms and symptom severity vs placebo irrespective of sex, race, ethnicity in adults with ADHD.
Short Description: This pooled analysis of two phase 3 trials assessed the impact of intrinsic factors on centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor-efficacy in adults with ADHD. CTN significantly improved core ADHD symptoms and severity versus placebo across sec, race, and ethnicity subgroups at Week 6. No significant treatment-by-subgroup interactions were observed, indicating consistent efficacy across populations.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc.
