Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: atomoxetine
Intervention description: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and
      emotional well being of children and adolescents with ADHD and to evaluate whether and in
      what measure the presence of comorbid conditions (internalizing and externalizing disorders)
      influences atomoxetine's ability to improve the quality of life of ADHD subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child or adolescent patients, male or female outpatients, who are at least 6 years of
             age, but must not yet have reached their 16th birthday prior to Visit 1, when informed
             consent is obtained

          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5
             standard deviations above the age norm for their diagnostic subtype using published
             norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity
             Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2

          -  Laboratory results, including serum chemistries, hematology, and urinalysis, must show
             no clinically significant abnormalities (clinically significant is defined as
             laboratory values requiring acute medical intervention, indicating a serious medical
             illness, or requiring further medical evaluation in the judgment of the investigator)

          -  An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the
             baseline/screening visit and the results must be reviewed by the investigator at Visit
             2 prior to dispensing of study material

          -  Patients and parents have been judged by the investigator to be reliable to keep
             appointments for clinic visits and all tests, including venipuncture, and examinations
             required by the protocol.

        Exclusion Criteria:

          -  Patients who have a documented history of Bipolar I or II disorder, any history of
             psychosis or pervasive development disorder

          -  Patients with a history of any seizure disorder (other than febrile seizures) or
             patients who have taken (or are currently taking) anticonvulsants for seizure control
             are not eligible to participate

          -  Patients at serious suicidal risk as assessed by the investigator

          -  Patients with significant cardiovascular disease or other conditions that could be
             aggravated by an increased heart rate or increased blood pressure

          -  Patients who have any medical condition that would increase sympathetic nervous system
             activity markedly (for example, catecholamine-secreting neural tumor), or who are
             taking a medication on a daily basis (for example, albuterol, inhalation aerosols,
             pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on
             an as-needed basis