Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Registration Number
- NCT00191633
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12.
- Patients must have moderately severe symptoms of ADHD.
- Patients must be able to swallow study drug capsules.
- Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
- Patients must not have taken atomoxetine prior to starting the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the correlation of change in score on an ADHD rating scale with the change in score on a functional rating questionnaire at 3 months post atomoxetine initiation
- Secondary Outcome Measures
Name Time Method Understand the relationships between ADHD symptoms, functional outcomes, and quality of life Explore the impact of data collection time points on efficacy, quality of life, and functional outcome Assess the efficacy of atomoxetine Use data collected to validate the WFIRS-P questionnaire
Related Research Topics
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Trial Locations
- Locations (2)
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.
🇨🇦Summerside, Prince Edward Island, 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
🇨🇦Saskatoon, Saskatchewan, 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.🇨🇦Summerside, Prince Edward Island, Canada