Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.
Interventions
DRUGAtomoxetine Hydrochloride
DRUGMethylphenidate Hydrochloride
DRUGPlacebo
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 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be at least 6 years of age and not more than 12 years of age at visit 1 * Patients must meet DSM-IV diagnostic criteria for ADHD * Patients must be retrospectively identified as stimulant non-responders * Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test) * Patients must be able to swallow capsules
Exclusion criteria
* Patients who weigh less than 22 kg or more than 60 kg at study entry * Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder * Patients who meet DSM-IV criteria for anxiety disorder or autism * Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control * Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by ECGs | — |
| Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by clinical laboratory tests | — |
| Assess the tolerability of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by spontaneously reported AEs | — |
| Compare the efficacy of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children | — |
Countries
United States
Outcome results
None listed