A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190931
First received: September 12, 2005
Last updated: July 21, 2006
Last verified: July 2006

September 12, 2005
July 21, 2006
November 2003
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00190931 on ClinicalTrials.gov Archive Site
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.
  • -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.
  • -To assess the efficacy of atomoxetine therapy in treatin
Not Provided
Not Provided
 
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Drug: Atomoxetine Hydrochloride
  • Drug: placebo
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
400
July 2005
Not Provided

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.
Both
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00190931
7066, B4Z-MC-LYBV
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
July 2006

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