Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.
Interventions
DRUGMethylphenidate Hydrochloride
DRUGAtomoxetine Hydrochloride
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Be at least 6 years of age and not more than 16 years of age at Visit 1 * Must meet DSM-IV criteria for ADHD * Must be of normal intelligence (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an IQ test) * Must be able to swallow capsules * Must have laboratory results that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
Exclusion criteria
* Weigh less than 20 kg or more than 60 kg at study entry * Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder * Meet DSM-IV criteria for an anxiety disorder * Have a history of any seizure disorder (other than febrile seizures)or prior ECG abnormalities related to epilepsy, or subjects who have taken or are currently taking anti-convulsants for seizure control * Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions,including a hypersensitivity to methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test the hypothesis that atomoxetine hydrochloride is non-inferior to methylphenidate hydrochloride in improving ADHD symptoms following an approximately 8-week period of double blind treatment as assessed by a comparison of response rates | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse events | — |
| To assess the comparability of the efficacy of atomoxetine and methylphenidate on the Conners' Parent Rating Scale-Revised: Short Form | — |
| To compare atomoxetine and methylphenidate on other secondary measures | — |
Countries
China, Mexico, South Korea
Outcome results
None listed