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

Tracking Information

First Received Date ^ICMJE

June 16, 2008

Last Updated Date

November 16, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00700427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: atomoxetine hydrochloride
Drug: placebo

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1925

Estimated Completion Date

June 2013

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

1-317-615-4559

Location Countries ^ICMJE

United States, Argentina, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00700427

Responsible Party

Chief Medical Officer, Eli Lilly

Study ID Numbers ^ICMJE

9655, B4Z-MC-LYDO

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP