Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Study Overview

• Status: Completed
• Conditions: Attention-Deficit/Hyperactivity Disorder; Comorbid Dyslexia
• Intervention / Treatment: Drug: Atomoxetine

• Study Type: Interventional
• Enrollment: 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Rolling Hills Estate, California, United States
      • 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
  • Florida
    • Maitland, Florida, United States
      • 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
    • Miami, Florida, United States
      • 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
  • Illinois
    • Libertyville, Illinois, United States
      • 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
  • Nevada
    • Las Vegas, Nevada, United States
      • 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
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • 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
  • Tennessee
    • Nashville, Tennessee, United States
      • 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
  • Vermont
    • Burlington, Vermont, United States
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ADHD only or ADHD and Dyslexia
• At least 10 years old and no more than 16 years old
• IQ score of 80 or more
• Must be able to swallow capsules

Exclusion Criteria:

• Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Weigh less than 25 kg or greater than 70 kg
• Pregnant or breast feeding
• Documented history of bipolar I or II disorder, or psychosis
• Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv

Secondary Outcome Measures

Outcome Measure
To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Sumner CR, Gathercole S, Greenbaum M, Rubin R, Williams D, Hollandbeck M, Wietecha L. Atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children with ADHD and dyslexia. Child Adolesc Psychiatry Ment Health. 2009 Dec 15;3:40. doi: 10.1186/1753-2000-3-40.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): January 26, 2007
• Last Update Submitted That Met QC Criteria: January 24, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Dyslexia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 7975; B4Z-US-LYCE