Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.

Phase 4

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00216918
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Study Completion: 2006-06
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.
2. Patients must have moderately severe symptoms of ADHD.
3. Patients must be able to swallow study drug capsules.

Exclusion Criteria

1. Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
2. Patients must not be home-schooled.

B) Controls:

Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.

Inclusion Criteria:

1. Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder

Exclusion Criteria:

1. Subjects must not be home-schooled.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.

Secondary Outcome Measures

Name	Time	Method
Assess changes in executive function and attention;Compare changes in neuropsychological status in a normal control group, gender and age matched to atomoxetine-treated patients at baseline and 6 months
Efficacy of atomoxetine after 2 and 6 months, or endpoint from baseline;Assess the correlation of change from baseline to 6 months, or at study discontinuation, in ADHD symptoms with change from baseline in the neuropsychological functioning
Assess the relationships of change from baseline to approximately 2 and 6 months, or endpoint in the core symptoms of ADHD with the changes in functional outcomes as assessed by the WFIRS-P
Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change.

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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇨🇦 Quebec, Canada