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

Verified by: Eli Lilly and Company, January 2010
First Received: May 7, 2007 | Last Updated: January 4, 2010 | Phase: Phase 4 | Start Date: April 2007
Overall Status: Completed | Estimated Enrollment: 228
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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...

Brief Summary

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No

Secondary Measures

  • Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

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

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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