Official Title: “Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study”

LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive under open label conditions atomoxetine up to 100 mg/day during the acute, open label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients or investigators know if patients receive atomoxetine or placebo).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2011

Intervention(s) in this Clinical Trial

• Drug: atomoxetine hydrochloride
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by atomoxetine, 80-100 mg/day, QD or BID, 37 weeks
• Placebo Comparator: 2
  • Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by placebo, oral, daily, 37 weeks

Primary Measures

• Proportion of patients who maintain a satisfactory response
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Number of days until relapse
  • Time Frame: 1 year
    Safety Issue?: No
• The change of Adult ADHD Quality of Life scores from baseline to end point
  • Time Frame: 1 year
    Safety Issue?: No

Inclusion Criteria:

• Adults
• Male or female
• Must meet ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria

Exclusion Criteria:

• Comorbidity with major psychiatric disorder
• Clinically significant depression or anxiety
• Patients with significant medical conditions
• Current alcohol/drugs abuse/dependence
• Concomitant excluded medications

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5hours, EST) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in the clinical trial 1-877-CTLILLY (1-877-285-4559), or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700427

Study ID Number: 9655

ClinicalTrials.gov Identifier: NCT00700427

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry