Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening

Inclusion Criteria:

• Adults ages 18-60 years, inclusive at the time of consent

• Able to provide signed informed consent

• Any gender

• Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentivepresentation, or combined presentations) as confirmed by the ACDS Version 1.2.5,Subjects who are not receiving any pharmacological treatment for ADHD must have anAISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who werepreviously receiving pharmacological treatment for ADHD at screening must have aminimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening

• Dysthymia and anxiety disorders in remission but stable on psychiatric medicationfor three weeks or more at the discretion of principal investigator will be allowed-medication for these disorders to remain constant for the duration of the protocol.

• Subjects who are stimulant naïve.

Exclusion Criteria:

• Known hypersensitivity to serdexmethylphenidate, methylphenidate, or productcomponents.

• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOIwithin the preceding 14 days.

• Lifetime bipolar disorder, psychotic disorders, autism, intellectual disabilityexcept mood disorders accepted under the inclusion criteria at the discretion of theprincipal investigator.

• Active suicidality within past year, or history of suicide attempt in past 2 years

• Any history of severe past drug dependence determined by the MINI (i.e., a focus ofclinical attention or a cause of substantial social or occupational difficulty)

• Concurrent substance abuse and/or history of substance use within 6 months

• Use of any prescribed benzodiazepine

• Any unstable medical or neurological condition; clinically significant medicalabnormalities such as cardiovascular abnormalities, and any chronic condition of thecentral nervous system.

• Any psychotropic medication usage

• Known nonresponse to MPH treatment

• History of allergic reaction or sensitivity to MPH

• Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnantor men planning to make a woman pregnant during the study or for one-month poststudy

• PI/clinician discretion