Status:
COMPLETED
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Dyslexia
Eligibility:
All Genders
10-16 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)
Eligibility Criteria
Inclusion
- patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00607919
Start Date
March 1 2008
End Date
February 1 2011
Last Update
December 15 2011
Active Locations (16)
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1
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.
Irvine, California, United States, 92612
2
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.
Palo Alto, California, United States, 94306
3
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.
San Francisco, California, United States, 94143
4
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.
New Haven, Connecticut, United States, 06511