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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.

Outcomes

Primary Outcome Measures

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 Measures

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.

Full Information

First Posted
September 12, 2005
Last Updated
July 21, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00190931
Brief Title
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Columbia
State/Province
Missouri
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25019647
Citation
Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
Results Reference
derived

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

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