Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.
Interventions
DRUGAtomoxetine Hydrochloride
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ADHD
Exclusion criteria
* Patients who weigh less than 20kg at visit 1 * Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures * Judged to be at suicidal risk * Taking psychotropic medication on a regular basis * Hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition) | — |
Secondary
| Measure | Time frame |
|---|---|
| The domains of the CHIP-CE after 4 and 10 weeks of treatment. | — |
| The following are measured after both 4 and 10 weeks of treatment: | — |
| Family Buden of Illness | — |
| Harter Self Perception Profile | — |
| CHIP-CE total mean score after 4 weeks of treatment. | — |
| Clinical Global Impression- Severity | — |
| Clinical Global Impression -Improvement | — |
| To assess whether changes to the above scales are maintained over long term | — |
| Long-term safety of atomoxetine | — |
| ADHD-RS | — |
Countries
United Kingdom
Outcome results
None listed