Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.
Interventions
DRUGAtomoxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12. * Patients must have moderately severe symptoms of ADHD. * Patients must be able to swallow study drug capsules.
Exclusion criteria
* Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder. * Patients must not have taken atomoxetine prior to starting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the correlation of change in score on an ADHD rating scale with the change in score on a functional rating questionnaire at 3 months post atomoxetine initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Understand the relationships between ADHD symptoms, functional outcomes, and quality of life | — |
| Explore the impact of data collection time points on efficacy, quality of life, and functional outcome | — |
| Assess the efficacy of atomoxetine | — |
| Use data collected to validate the WFIRS-P questionnaire | — |
Countries
Canada
Outcome results
None listed