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Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191633
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes

September 12, 2005
January 24, 2007
April 2005
Not Provided
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
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.
Complete list of historical versions of study NCT00191633 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes
A 3 Month Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder; Symptomatic and Functional Outcomes.

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
Drug: Atomoxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2006
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00191633
9684, B4Z-CA-S012
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP