A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
Completed · Phase 4 · Has a placebo group
Conditions studied: Attention Deficit Disorder With Hyperactivity
In brief
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.
Key facts
- Study ID
- NCT00190931
- Run by
- Eli Lilly and Company
- People needed
- 400
- Starts
- 2003-11-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2006-07-24
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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