Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
Interventions
DRUGAtomoxetine 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 16 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria * Subjects must be aged 6 to 16 years * Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures * Subjects must be able to swallow capsules * Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
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 as assessed by the investigator * 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) anticonvulsants for seizure control * Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo | — |
| Compare the reduction in school-related symptoms between atomoxetine and placebo | — |
| Assess the safety and tolerability of once-daily dosing of atomoxetine | — |
Countries
Taiwan
Outcome results
None listed