Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
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| ClinicalTrials.gov Identifier: NCT00216918 |
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Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : January 26, 2007
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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 |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Drug: Atomoxetine Hydrochloride | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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. |
| Study Start Date : | September 2005 |
| Study Completion Date : | June 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Attention-deficit/hyperactivity disorder
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
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.
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| 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.
Information from the National Library of Medicine
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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00216918 |
| Other Study ID Numbers: |
9721 B4Z-CA-S013 |
| First Posted: | September 22, 2005 Key Record Dates |
| Last Update Posted: | January 26, 2007 |
| Last Verified: | January 2007 |
Additional relevant MeSH terms:
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Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |
Atomoxetine Hydrochloride Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |