A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: Atomoxetine Hydrochloride (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Test the hypothesis that, compared with placebo, administration of atomoxetine for approximately 6 months will result in an improved work productivity,as measured on the Endicott Work Productivity Scale (EWPS) during Study Period II.
Secondary outcome: To assess the efficacy of atomoxetine in treating core symptoms in adults during Study Period II using the Conners'Adult Attention Deficit/Hyperactivity Disorder Rating Scale-Investigator rated.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Meet DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
2. Have a CGI-S-ADHD score of 4 (moderate symptoms) or greater at Visit 1 and Visit 2.
3. Adult Men or Women, 18 years of age or older and not more than 50 years of age at
Visit 1.
4. Laboratory results must show no clinically significant abnormalities.
5. 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 Criteria:
1. 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.
2. Are pregnant or are breastfeeding.
3. Have organic brain disease. Have a history of any seizure disorder or patients who
have taken or are currently taking anticonvulsants for seizure control.
4. 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.
5. Are unstable in any way to participate in this study, in the opinion of the
investigator.
Locations and Contacts
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
Additional Information
Starting date: November 2003
Ending date: July 2005
Last updated: July 21, 2006
|
