Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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. []
Eligibility Criteria
Criteria
A) Patients:
Inclusion Criteria:
-
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.
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Patients must have moderately severe symptoms of ADHD.
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Patients must be able to swallow study drug capsules.
Exclusion Criteria:
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Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
-
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:
- Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder
Exclusion Criteria:
- Subjects must not be home-schooled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | G1R 2W8 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9721
- B4Z-CA-S013