Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00191880
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-06
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-24
• Last Update Posted: 2006-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12.

Exclusion Criteria

-Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess the correlation of change from baseline to one year in ADHD symptoms as measured by the Attention Deficit/Hyperactivity Disorder Rating Scale- IV-
Parent Version: Investigator Administered and Scored,
total score, with change from baseline in academic achievement of medication-naive patients treated with atomoxetine at one year as measured by the total
of the composite scores of the broad reading, broad math, and broad language subtests of the Woodcock-Johnson Tests of Achievement (WJII)

Secondary Outcome Measures

Name	Time	Method
To Assess the correlation of change from baseline to one year or at study discontinuation in ADHD symptoms as measured by the ADHDRS-IV-Parent:Inv with change from baseline with each of the academic achievement composite scores of the broad reading, broa

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician; 🇨🇦 Toronto, Canada