A 3 Month Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder; Symptomatic and Functional Outcomes.

Eli Lilly and Company2 sites in 1 country200 target enrollmentApril 2005

ConditionsAttention-Deficit/Hyperactivity Disorder

DrugsAtomoxetine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 200
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

June 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

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 Outcomes

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