A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

Lilly

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00471354

B4Z-CR-S018

11098

Details and patient eligibility

About

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

Enrollment

228 patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female outpatients between 8 and 11 years of age at study entry
Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
Normal intelligence in the judgment of the investigator
Must be able to swallow capsules

Exclusion criteria

Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
History of seizure disorder or currently taking anticonvulsants for seizure control
Serious suicidal risk as determined by investigator
Cardiovascular disease; current or past history of hypertension
Previous treatment with atomoxetine