Attention Deficit Disorder With Hyperactivity
Conditions
Brief summary
The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.
Interventions
DRUGatomoxetine
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
* Subjects must have ADHD that meets the DSM-IV criteria * Aged 6 to 16 years. * Subjects must not have taken any medication used to treat ADHD. * Laboratory results must show no significant abnormalities * Baseline ECG results must not show an abnormality * Subjects must be able to swallow capsules. * Subjects must be of normal intelligence.
Exclusion criteria
* Weigh less than 20 kg or more than 60 kg at study entry. * Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating. * Have a history of Bipolar I or II disorder, psychosis, or PDD. * Meet DSM-IV criteria for an anxiety disorder. * Have a history of any seizure disorder. * Patients at serious suicidal risk. * Patients with narrow angle glaucoma * Subjects who have a history of severe allergies . * Have a history of alcohol or drug abuse within the past 3 months * Screen positive for drugs of abuse not prescribed by a physician. * Have cardiovascular disease and an increased heart rate and blood pressure. * Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis. * Have severe gastrointestinal narrowing * Are during the study time likely to need psychotropic medications. * Are likely to begin a structured psychotherapy aimed at ADHD symptoms. * Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks * Female subjects who are pregnant or who are breast-feeding. * Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * Are, in the opinion of the investigator, unsuitable in any other way to participate in this study. * Are employed by Lilly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners | — |
| To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents | — |
Countries
Russia
Outcome results
None listed