A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: TD-9855; TD-9855; Placebo
Intervention description: Once daily; Once daily; Once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Adult ADHD; Attention-Deficit/Hyperactivity Disorder

Summary:

      The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be
      evaluated in adult males with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet the following ADHD diagnostic and inclusion criteria:

          -  Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined
             type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive
             type) as assessed by the clinical interview and confirmed by Adult
             Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).

          -  Subjects must have a total score of 24 or greater on the AISRS at both the Screening
             and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20%
             from Screening.

          -  Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and
             Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.

          -  For women of childbearing potential, documentation of a negative serum pregnancy test
             at Screening and a negative urine pregnancy test on Day 0. All female subjects of
             childbearing potential must be using a highly effective method of birth control during
             the study and for at least 1 month after completion of study drug dosing.

          -  A highly effective method of birth control is defined as one that results in a low
             failure rate (i.e., <1% per year) when used consistently and correctly, such as condom
             + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD]
             with documented failure rate of <1% per year, or oral/injectable/implanted hormonal
             contraceptives used in combination with a barrier method.

          -  Women are considered to be not of childbearing potential if they have had a total
             hysterectomy or bilateral tubal ligation (documentation for either must be provided
             before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be
             breast-feeding.

        Exclusion Criteria:

        Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by
        Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not
        require pharmacological treatment will not be excluded.

          -  MADRS total score >15.

          -  A diagnosis of ADHD NOS.

          -  Any diagnosis of lifetime bipolar disorder or psychotic disorder

          -  A current diagnosis of any severe comorbid Axis II disorder

          -  Any history of mental retardation, organic mental disorders due to general medical
             condition or pervasive developmental disorder as defined by DSM-IV-TR.-