Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.
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 at least 6 years of age and not yet be 18 years of age at the completion of visit 6 * Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype) * Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) * 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 a IQ test) * Patients must be able to swallow capsules
Exclusion criteria
* Patients who weigh less than 22 kg or more than 70 kg at study entry * Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder * Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, 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 * Patients who have glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine | — |
| Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning. | — |
| Compare atomoxetine and stimulant medications on other secondary measures, including parent preference | — |
| Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine | — |
| Assess the change in inattentive and hyperactive symptoms among these same patients | — |
Countries
United States
Outcome results
None listed