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A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study is currently recruiting participants.
Verified by Eli Lilly and Company, November 2009
First Received: June 16, 2008   Last Updated: November 16, 2009   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00700427
  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 III

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


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: June 2013
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Placebo Comparator
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by placebo, oral, daily, 37 weeks
Drug: atomoxetine hydrochloride 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

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

  Hide Study Locations
Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Beverly Hills, California, United States, 90210
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National City, California, United States, 91950
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Newport Beach, California, United States, 92660
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Sherman Oaks, California, United States, 91403
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Torrance, California, United States, 90502
United States, Connecticut
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Farmington, Connecticut, United States, 06030
United States, Florida
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Gainesville, Florida, United States, 32606
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Orlando, Florida, United States, 32806
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Atlanta, Georgia, United States, 30308
United States, Indiana
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Lafayette, Indiana, United States, 47905
United States, Kansas
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67114
United States, Louisiana
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Lake Charles, Louisiana, United States, 70601
United States, Maryland
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Fall River, Massachusetts, United States, 02721
United States, New York
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Brooklyn, New York, United States, 11214
United States, North Carolina
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Raleigh, North Carolina, United States, 27609
United States, Ohio
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Canton, Ohio, United States, 44718
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Toledo, Ohio, United States, 43609
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Willoughby, Ohio, United States, 44094
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97210
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Salem, Oregon, United States, 97301
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18104
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Philadelphia, Pennsylvania, United States, 19131
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Scranton, Pennsylvania, United States, 18503
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Sellersville, Pennsylvania, United States, 18960
United States, Rhode Island
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Lincoln, Rhode Island, United States, 02865
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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Houston, Texas, United States, 77042
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San Antonio, Texas, United States, 78258
United States, Utah
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Clinton, Utah, United States, 84015
United States, Vermont
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Burlington, Vermont, United States, 05401
United States, Washington
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Bellevue, Washington, United States, 98007
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Seattle, Washington, United States, 98104
Argentina
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Buenos Aires, Argentina, C1425CDC
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La Plata, Argentina, 1900
Austria
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Innsbruck, Austria, 6020
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Vienna, Austria, A1090
Contact: Eli Lilly            
Belgium
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Brugge, Belgium, 8310
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Mechelen, Belgium, 2800
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Kortenberg, Belgium, 3070
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Liege, Belgium, 4000
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Kontich, Belgium, 2550
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Nieuwkerken-Waas, Belgium, 9100
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Uccle, Belgium, 1180
Contact: Eli Lilly            
Canada, Alberta
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Edmonton, Alberta, Canada, T6K 3J4
Contact: Eli Lilly            
Canada, British Columbia
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Vancouver, British Columbia, Canada, V6Z 2L4
Contact: Eli Lilly            
Canada, Nova Scotia
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Sydney, Nova Scotia, Canada, B1P 1C6
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Canada, Ontario
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Barrie, Ontario, Canada, L4M 5A1
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Whitby, Ontario, Canada, L1N 8M7
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Canada, Quebec
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Montreal, Quebec, Canada, H3P 3E5
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Sherbrooke, Quebec, Canada, J1H1Z1
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Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Eli Lilly            
Denmark
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Frederiksberg, Denmark, 2000
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Odense, Denmark, DK-5000
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Finland
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Helsinki, Finland, 00029 HUS
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Tampere, Finland, 33100
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Turku, Finland, 20100
Contact: Eli Lilly            
France
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Bordeaux, France, 33076
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Douai, France, 59500
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Marseille, France, 13009
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Montpellier, France, 34 295
Contact: Eli Lilly            
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Nice, France, 06200
Contact: Eli Lilly            
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Orvault, France, 44000
Contact: Eli Lilly            
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Paris, France, 75014
Contact: Eli Lilly            
Germany
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Ahrensburg, Germany, 22926
Contact: Eli Lilly            
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Berlin, Germany, D-14050
Contact: Eli Lilly            
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Homburg, Germany, 66421
Contact: Eli Lilly            
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Ellwangen, Germany, 73479
Contact: Eli Lilly            
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Essen, Germany, D-45147
Contact: Eli Lilly            
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Freiburg, Germany, 79104
Contact: Eli Lilly            
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Fulda, Germany, 36037
Contact: Eli Lilly            
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Hamburg, Germany, D-20251
Contact: Eli Lilly            
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Hannover, Germany, 30625
Contact: Eli Lilly            
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Bochum, Germany, 44791
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Leipzig, Germany, 04157
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Ludwigshafen, Germany, 67071
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Mainz, Germany, 55131
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Mannheim, Germany, 68159
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Munich, Germany, 80333
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Wurzburg, Germany, 97070
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Italy
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Coppito, Italy, 67100
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Milano, Italy, 20121
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Palermo, Italy, 90129
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Rome, Italy, 00168
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San Donà Di Piave, Italy, 30027
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Mexico
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Insurgentes Cuicuilco, Mexico, 04530
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Monterrey, Mexico, 64810
Netherlands
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Amersfoort, Netherlands, 3816 CP
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Den Haag, Netherlands, 2593 HR
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Hengelo, Netherlands, 7555 DL
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Leeuwarden, Netherlands, 8933 AD
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Nijmegen, Netherlands, 6500 HB
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Tilburg, Netherlands, 5037 SK
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Vlissingen, Netherlands, 4382 EE
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Portugal
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Coimbra, Portugal, 3030
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Cascais, Portugal, 2750-782
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Puerto Rico
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Bayamon, Puerto Rico, 00961
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Caguas, Puerto Rico, 00725
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Ponce, Puerto Rico, 00731-7779
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San Juan, Puerto Rico, 00907
Spain
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Alcorcon, Spain, 28922
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Barcelona, Spain, 08035
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Zaragoza, Spain, 50009
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Pamplona, Spain, 31008
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Zamora, Spain, 49021
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Madrid, Spain, 28041
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Sweden
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Lulea, Sweden, SE 972 35
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Lund, Sweden, 22361
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Malmo, Sweden, 21135
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Vaxjo, Sweden, SE 351 88
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Switzerland
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Zurich, Switzerland, 8008
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Basel, Switzerland, 4055
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Lausanne, Switzerland, 1005
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Baden-Daettwil, Switzerland, CH-5405
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United Kingdom
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London, United Kingdom, SE5 8AZ
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United Kingdom, East Sussex
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Brighton, East Sussex, United Kingdom, BN2 3EW
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United Kingdom, Middlesex
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Edgware, Middlesex, United Kingdom, HA8 0AD
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United Kingdom, Northampton
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Upton, Northampton, United Kingdom, NN5 6UH
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United Kingdom, Surrey
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West Molesey, Surrey, United Kingdom, KT8 2QG
Contact: Eli Lilly            
United Kingdom, Swansea
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Cockett, Swansea, United Kingdom, SA2 0GH
Contact: Eli Lilly            
United Kingdom, West Sussex
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Storrington, West Sussex, United Kingdom, RH20 4NQ
Contact: Eli Lilly            
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:
No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 9655, B4Z-MC-LYDO
Study First Received: June 16, 2008
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00700427     History of Changes
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:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine
Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 27, 2009