Status:
COMPLETED
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-49 years
Phase:
PHASE4
Brief Summary
The overall primary objective of this study is to test the hypothesis that, compared with placebo,administration of atomoxetine will result in an improved work productivity.
Eligibility Criteria
Inclusion
- Meet DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
- Have a CGI-S-ADHD score of 4 (moderate symptoms) or greater at Visit 1 and Visit 2.
- Adult Men or Women, 18 years of age or older and not more than 50 years of age at Visit 1.
- Laboratory results must show no clinically significant abnormalities.
- Paid employees working 20 hours or more per week and who have been paid in their current place of employment for 6 months or more.
Exclusion
- Meet diagnostic criteria for current major depression, a current anxiety disorder and history of bipolar disorder or any history of a psychotic disorder will be excluded from the study.
- Are pregnant or are breastfeeding.
- Have organic brain disease. Have a history of any seizure disorder or patients who have taken or are currently taking anticonvulsants for seizure control.
- Are taking any psychotropic medication on a regular basis that has central nervous system activity. Must have a washout equal to a minimum of 5 half-lives of that medication prior to Visit 2.
- Are unstable in any way to participate in this study, in the opinion of the investigator.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00190931
Start Date
November 1 2003
End Date
July 1 2005
Last Update
July 24 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
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.
Columbia, Missouri, United States