Status:
COMPLETED
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- A) Patients:
- 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.
- Patients must have moderately severe symptoms of ADHD.
- Patients must be able to swallow study drug capsules.
Exclusion
- 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:
- 1\) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00216918
Start Date
September 1 2005
End Date
June 1 2006
Last Update
January 26 2007
Active Locations (1)
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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.
Québec, Quebec, Canada, G1R 2W8