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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2011

Intervention(s) in this Clinical Trial

• 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
• Drug: Placebo
  • oral, daily, for 16 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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
• Placebo Comparator: 2
  • Placebo will be packaged in the same way as experimental drug to enforce double-blind study design

Primary Measures

• To assess the efficacy of atomoxetine in treating children and adolescents with ADHD and comorbid dyslexia.
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary 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
    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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY(1-877-285-4559) 1-317-615-4559 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607919

Study ID Number: 11672

ClinicalTrials.gov Identifier: NCT00607919

Health Authority: United States: Food and Drug Administration

(Lilly Clinical Trial Registry)