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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

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