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Completed

NCT Number: NCT00190931

A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With 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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

Important dates

Study start
2003
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Jul 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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