Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD &Comorbid Dyslexia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00607919

Purpose

This study will evaluate the effect of atomoxetine in treating ADHD symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder Dyslexia	Drug: Atomoxetine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess the efficacy of atomoxetine in treating children and adolescents with ADHD and comorbid dyslexia. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess effect of atomoxetine on basic reading skills,working memory, social, emotional, cognitive, educational, and affiliative functioning, inattentive symptoms, & self concept. [ Time Frame: 16 to 32 weeks ] [ Designated as safety issue: No ]
To assess the safety & tolerability of atomoxetine in treating children & adolescent with ADHD and comorbid dyslexia. [ Time Frame: 16 to 32 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	205
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine	Drug: Atomoxetine Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks
2: Placebo Comparator Placebo will be packaged in the same way as experimental drug to enforce double-blind study design	Drug: Placebo oral, daily, for 16 weeks

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients must meet DSM-IV criteria for ADHD
patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
child or adolescent patients must be 10 to 16 years old
must be able to communicate in English
must be able to swallow capsules
be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

patients who weigh less than 25 Kg or greater than 70 Kg
patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
females who are pregnant or breastfeeding
patients with a history of severe allergy to more than one class of medications
patients with documented history of bipolar I or bipolar II disorder, or psychosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607919

Contacts

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

1-317-615-4559

Locations

United States, Arizona
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.	Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Eli Lilly
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.	Recruiting
Irvine, California, United States, 92612
Contact: Eli Lilly
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.	Recruiting
Palo Alto, California, United States, 94306
Contact: Eli Lilly
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.	Recruiting
San Francisco, California, United States, 94143
Contact: Eli Lilly
United States, Connecticut
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.	Recruiting
New Haven, Connecticut, United States, 06511
Contact: Eli Lilly
United States, Florida
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.	Recruiting
Tampa, Florida, United States, 33607
Contact: Eli Lilly
United States, Illinois
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.	Not yet recruiting
Springfield, Illinois, United States, 62703
Contact: Eli Lilly
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.	Recruiting
Libertyville, Illinois, United States, 60048
Contact: Eli Lilly
United States, Indiana
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.	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Eli Lilly
United States, Kentucky
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.	Recruiting
Lexington, Kentucky, United States, 40509
Contact: Eli Lilly
United States, North Carolina
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.	Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Eli Lilly
United States, Ohio
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.	Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Eli Lilly
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.	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Eli Lilly
United States, Oklahoma
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.	Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Eli Lilly
United States, Pennsylvania
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.	Recruiting
Pittsburgh, Pennsylvania, United States, 15241
Contact: Eli Lilly
United States, Texas
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.	Recruiting
San Antonio, Texas, United States, 78229
Contact: Eli Lilly
United States, Vermont
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.	Recruiting
Burlington, Vermont, United States, 05401
Contact: Eli Lilly
United States, Washington
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.	Recruiting
Spokane, Washington, United States, 99202
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 - 5 hours, 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 ( Chief Medical Officer )
Study ID Numbers:	11672, B4Z-US-LYEB
Study First Received:	January 23, 2008
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00607919 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Atomoxetine
Attention Deficit and Disruptive Behavior Disorders
Dyslexia

Language Disorders
Learning Disorders
Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Neurobehavioral Manifestations
Communication Disorders

ClinicalTrials.gov processed this record on November 20, 2009