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).
Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
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 disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
Single group
Centanafadine XR
DrugOral capsules
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
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