Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder

Inclusion Criteria

• Participants had to be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
• Participants must have met DSM-IV-TR diagnostic criteria for ADHD (Combined, Predominantly Inattentive or Predominantly Hyperactive-Impulsive Types) on the M.I.N.I.-Plus.
• Participants must have had an ADHD-RS-IV score of greater than or equal to 28 at the placebo run-in baseline and CTN SR treatment baseline.
• Participants must have had a Clinical Global Impression of Severity (ADHD version) score of greater than or equal to 4.
• Participants must be able to read well enough to understand the informed consent form and other participant materials.
• Participants must have been able to be reliably rated on the psychiatric scales required by the protocol based on investigator's judgment.
• Participants must have been able to read and understand English.
• Participants must have had a body mass index of approximately 18 to 35 kilograms/meter squared.
• Sexually active, fertile males must have used effective birth control if their partners were women of childbearing potential. Women of childbearing potential (if a partner of a male participant) included any female who had experienced menarche and who had not undergone successful surgical sterilization or women on hormone replacement therapy with documented serum follicle stimulating hormone level greater than 35 milli-international units/milliliter. Even women who were using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or were practicing abstinence or where the partner was sterile (for example, vasectomy), should have been considered to be of childbearing potential.

Exclusion Criteria

• Participant had a DSM-IV-TR diagnosis of ADHD not otherwise specified.
• Participants rated as having a greater than or equal to 30% improvement in ADHD symptoms or a score of less than 28 on the ADHD-RS-IV after Week 1 (placebo run-in). Such participants were withdrawn from the study prior to receiving any active drug.
• Participant had a current or lifetime history of bipolar disorder or any psychotic disorder as established by M.I.N.I.-Plus.
• Participant had a current history (past 90 days) of major depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder or post-traumatic stress disorder as established by the M.I.N.I.-Plus.
• History in the past 20 years of electroconvulsive therapy or lifetime history of vagal nerve stimulation or deep brain stimulation for the treatment of depression.
• Participants with a history of drug or alcohol use disorders (abuse or dependence) must have been free of the diagnosis and of substance use for at least 6 months prior to the Screening visit.
• Participant had a history of epilepsy, seizures, syncope, unexplained blackout spell(s), head trauma with clinically significant loss of consciousness or noninfantile febrile seizures.
• Participant had a currently active medical condition (other than ADHD) that, in the opinion of the investigator, could have interfered with the ability of the participant to participate in the study safely.
• Participant had a history of clinically significant, diagnosed cardiovascular disease of any kind, including uncontrolled hypertension. Participant had newly diagnosed cardiovascular disease of any kind in the investigator's judgment.
• The participant had an intelligence quotient less than 80.
• In the opinion of the investigator, the participant had not derived significant therapeutic benefit from 2 or more ADHD therapies given with an adequate dose and duration in adulthood (age 18 or older); t