A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

Inclusion Criteria:

• Males and females aged 4 to 12 years (inclusive) at the time of informedconsent/assent.

• A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with theMINI-KID.

• A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline for allsubjects.

• A score of 4 or higher on the CGI-S-ADHD at baseline.

• Subjects aged 4 or 5 years only: has failed adequate psychotherapy or in theinvestigator's opinion, is severe enough to require pharmacotherapy in the absenceof prior psychotherapy.

Exclusion Criteria:

• Comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that issevere enough to interfere with trial procedures, Panic Disorder, Conduct Disorder,Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism SpectrumDisorder, Oppositional Defiant Disorder that is severe enough to interfere withtrial conduct (allowed if it is not the primary focus of treatment),Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current majordepressive episode.

• 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. A history ofsuicidal behavior (over the last 6 months).

• BMI ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US 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.