Otsuka Pharmaceutical Development & Commercialization, Inc.
The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).
Inclusion Criteria 1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS). 2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline. 3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline. 4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline. Exclusion Criteria 1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality…
Oral capsules