Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients 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 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients must be 6 - 18 years of age * Patients must meet DSM-IV diagnostic criteria for ADHD * Patient must be able to swallow capsules * Patients must be of normal intelligence * Laboratory results must show no significant abnormalities
Exclusion criteria
* Patients who weigh less than 15 kg or more than 75 kg at study entry * Patients who have a documented history of bipolar disorder or any history of psychosis * Patients taking any antipsychotic medication within 26 weeks of visit 1 * Patients with a severe history of allergies * Patients taking methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy. | — |
| To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine | — |
Countries
Japan
Outcome results
None listed