Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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.