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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00700427
First received: June 16, 2008
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: atomoxetine hydrochloride
Drug: placebo
 Phase 3

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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of patients who maintain a satisfactory response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days until relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The change of Adult ADHD Quality of Life scores from baseline to end point [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1925
Study Start Date: June 2008
Estimated Study Completion Date: October 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by atomoxetine, 80-100 mg/day, QD or BID, 37 weeks
 Drug: atomoxetine hydrochloride
Other Names:
  • Strattera
  • LY139603
Placebo Comparator: 2
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by placebo, oral, daily, 37 weeks
 Drug: atomoxetine hydrochloride
Other Names:
  • Strattera
  • LY139603
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700427

  Show 56 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00700427     History of Changes
Other Study ID Numbers: 9655, B4Z-MC-LYDO
Study First Received: June 16, 2008
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
ADHD
Adult
long term
maintenance of response
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013