Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
Interventions
DRUGAtomoxetine Hydrochloride
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 10 Years
Healthy volunteers
No
Inclusion criteria
A) Patients: Inclusion Criteria: 1. Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11. 2. Patients must have moderately severe symptoms of ADHD. 3. Patients must be able to swallow study drug capsules.
Exclusion criteria
1. Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder. 2. Patients must not be home-schooled. B) Controls: Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients. Inclusion Criteria: 1\) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess changes in executive function and attention;Compare changes in neuropsychological status in a normal control group, gender and age matched to atomoxetine-treated patients at baseline and 6 months | — |
| Efficacy of atomoxetine after 2 and 6 months, or endpoint from baseline;Assess the correlation of change from baseline to 6 months, or at study discontinuation, in ADHD symptoms with change from baseline in the neuropsychological functioning | — |
| Assess the relationships of change from baseline to approximately 2 and 6 months, or endpoint in the core symptoms of ADHD with the changes in functional outcomes as assessed by the WFIRS-P | — |
| Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change. | — |
Countries
Canada
Outcome results
None listed