Attention Deficit Disorder With Hyperactivity
Conditions
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.
Interventions
DRUGAtomoxetine Hydrochloride
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed