Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: atomoxetine; Behavior Modification Therapy
Intervention description: open label treatment dosed up to 1.8mg/kg/day; 8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; Atomoxetine; Behavior Therapy

Summary:

      Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there
      is only one published study specifically designed to evaluate its efficacy in school
      settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3
      mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However,
      children are typically referred for treatment because of "real life" problems in functioning,
      not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce
      functional improvements at home, the Weiss study found limited results in this area at
      school.

      Furthermore, almost no research has examined the effects of combining ATX and behavior
      therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of
      hyperactivity/impulsivity and increased the number of subjects reaching optimal response
      (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve
      functional performance in the classroom. The effects of combined therapy may be even larger
      for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.

      Objective: The primary objective was to evaluate the effects of ATX alone and in combination
      with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed
      using traditional symptoms measures as well as functional measures of academic and behavioral
      improvements in the classroom.
    

Eligibility criteria:

        Inclusion Criteria:

          1. meet DSM-IV diagnostic criteria for ADHD-combined type;

          2. estimated IQ of 75 or higher;

          3. agree to comply with the randomly assigned treatment condition;

          4. enrolled in full time school at first grade level or higher; AND

          5. have a primary teacher available to complete ratings for the entire study duration.

        Exclusion Criteria:

          1. current or past history of seizures (not including benign febrile seizures) or other
             neurological disorders;

          2. physical conditions that preclude administration of Strattera or other medical illness
             that might confound study results or increase the safety risk to subjects exposed to
             study treatments (i.e. marked cardiac conduction delay, etc.);

          3. prior failed trial of Strattera defined as 3 weeks or more on a daily dose of
             Strattera of at least .8mg/kg or a documented inability to tolerate at least
             .8mg/kg/day;

          4. serious forms of psychopathology other than ADHD, such autism, bipolar disorder,
             schizophrenia or any other psychopathology requiring urgent treatment with
             psychotropic medication; OR

          5. children for whom discontinuation of their current psychotropic medication would
             represent a serious risk to themselves or others.

        The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning
        disabilities will not result in exclusion from the study as they are commonly occurring
        comorbidities that have not been found to moderate response to ADHD treatments (Jensen et
        al., 2001). Enrollment in special education services will also not be an exclusionary
        criteria as work by this research group has found that such services do not affect response
        to ADHD treatments (Niemic, Fabiano, Pelham, & Fuller, 2002).