A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Verified by: Eli Lilly and Company, October 2011
First Received: June 16, 2008 | Last Updated: October 7, 2011 | Phase: Phase 3 | Start Date: June 2008
Overall Status: Active, not recruiting | Estimated Enrollment: 1925
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: August 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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