Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00216918|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Atomoxetine Hydrochloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study of Atomoxetine Hydrochloride to Evaluate Neuropsychological Function in Children Ages 6 to 10 Years With Attention-Deficit/Hyperactivity Disorder.|
|Study Start Date :||September 2005|
|Study Completion Date :||June 2006|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216918
|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|
|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|