Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

Exclusion criteria

• . If female and of child-bearing potential, the subject must not be pregnant or breastfeeding at any time during the study or for 30 days following the completion of the study. If of child-bearing potential, urine hCG tests will be administered at protocol specified time points. Any positive pregnancy test during the study will exclude them from further participation in the study.
• . Subject has any psychiatric diagnosis of bipolar I or II disorder, current major depressive disorder, conduct disorder, disruptive mood dysregulation disorder, intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances, or any other diagnosis/significant medical history that at the discretion of the Investigator excludes the subject from entry into the study.
• . Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS-related disorders that might occur in childhood, or history of persistent neurological symptoms related to a serious head injury.
• . Subject has any clinically significant and/or unstable medical abnormality, chronic medical condition, persistent neurological symptoms, history of cardiovascular abnormality, abnormalities of respiratory, hepatic, gastrointestinal, renal, or any disorder or history of a condition that would impact or interfere with drug absorption, distribution, metabolism, or excretion during the study or may interfere with the participants ability to participate in the study.
• . Subject has family history of early cardiovascular disease or sudden death.
• . Subject has any history of attempted suicide or clinically significant suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment, or answers "yes" to "Suicidal Ideation" item 4 or 5 in the past 3 years on the C-SSRS lifetime/recent assessment at Screening.
• . Subject has history of seizures, excluding febrile seizures.
• . Subject has a known primary sleep disorder (e.g., sleep apnea, narcolepsy, etc.)