Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks
Interventions
DRUGAtomoxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have ADHD. * Must be 13-16 years of age. * Must be able to swallow capsules. * Expected to achieve score of 70 or more on IQ test * Willing and reliable to keep appts. for clinic visits and test
Exclusion criteria
* Treatment within last 30 days with a drug that has not received regulatory approval for any indication. * Patients who weigh less than 40 kg or greater than 70 kg. * Patients with documented history of Bipolar I or II disorder, or psychosis * Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks | — |
Countries
United States
Outcome results
None listed