Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
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.

Official Title
-----------------
Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: atomoxetine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atomoxetine|nan|
|Drug: placebo|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |