Back to resultsNeuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility 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.
Sites / Locations
- 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.
Outcomes
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.
Full Information
NCT ID
NCT00216918
First Posted
September 20, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00216918
Brief Title
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
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 Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Quebec
ZIP/Postal Code
G1R 2W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21569378
Citation
Dickson RA, Maki E, Gibbins C, Gutkin SW, Turgay A, Weiss MD. Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Child Adolesc Psychiatry Ment Health. 2011 May 11;5:14. doi: 10.1186/1753-2000-5-14.
Results Reference
derived
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Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
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