Official Title: “Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • atomoxetine 0.5 mg/kg/day QD, PO starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• Correlation between ADHD symptoms by Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score with academic performance by School Grade Average
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Correlation between ADHD symptoms by ADHDRS-IV-Parent:Inv total score with academic performance in each of the school grades for language, Maths and Science classes
  • Time Frame: 24 weeks
    Safety Issue?: No
• Academic performance by School Grade Average (SGA)
  • Time Frame: 24 weeks
    Safety Issue?: No
• ADHDRS-IV-Parent:Inv total score
  • Time Frame: 24 weeks
    Safety Issue?: No
• Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity scale (CGI-ADHD-S)
  • Time Frame: 24 weeks
    Safety Issue?: No
• CGI-ADHD-Improvement scale (CGI-ADHD-I)
  • Time Frame: 24 weeks
    Safety Issue?: No
• Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S)
  • Time Frame: 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female outpatients between 8 and 11 years of age at study entry
• ADHD meeting the 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471354

Study ID Number: 11098

ClinicalTrials.gov Identifier: NCT00471354

Health Authority: China: Ethics Committee

Lilly Clinical Trial Registry