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Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00216918
First received: September 20, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Drug: Atomoxetine Hydrochloride | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 6 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
- Patients must have moderately severe symptoms of ADHD.
- Patients must be able to swallow study drug capsules.
Exclusion Criteria:
- 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
Exclusion Criteria:
1) Subjects must not be home-schooled.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00216918
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216918
Locations
| Canada | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00216918 History of Changes |
| Other Study ID Numbers: |
9721 B4Z-CA-S013 |
| Study First Received: | September 20, 2005 |
| Last Updated: | January 24, 2007 |
Additional relevant MeSH terms:
|
Disease Attention Deficit Disorder with Hyperactivity Hyperkinesis Pathologic Processes Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Atomoxetine Hydrochloride Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 13, 2017