A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Inclusion Criteria:

• Males and females aged 13 to 17 years (inclusive) at the time of informedconsent/assent.

• A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of MentalDisorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the MiniInternational Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

• A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/HyperactivityDisorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.

• A score of 4 or higher on the Clinical Global Impression - Severity - AttentionDeficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.

Exclusion Criteria:

• A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severeenough to interfere with trial procedures, Panic Disorder, Conduct Disorder,Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism SpectrumDisorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disordersevere enough to interfere with trial conduct (allowed if it is not the primaryfocus of treatment), Obsessive-Compulsive Disorder severe enough to interfere withtrial conduct (allowed if it is not the primary focus of treatment), or majordepressive disorder (MDD) with current major depressive episode.

• Participants who are breast-feeding and/or have a positive pregnancy test resultprior to receiving investigational medicinal product (IMP).

• A significant risk of committing suicide based on history and the investigator'sclinical judgment, or routine psychiatric status examination, Current suicidalbehavior, Imminent risk of injury to self, Active suicidal ideation. History ofsuicidal behavior (over the last 6 months).

• Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based onUnited States (US) Centers for Disease Control and Prevention (CDC) criteria.

• Has initiated, changed, or discontinued receiving psychological interventions forADHD within the 30 days before the screening visit, or is anticipated to start newtreatment during the trial.