Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

Last updated: October 9, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

4

Condition

Williams Syndrome

Dyslexia

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

N/A

Clinical Study ID

NCT00716274
12212
B4Z-US-LYEI
2019-000419-98
  • Ages 10-16
  • All Genders

Study Summary

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria forADHD
  • Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteriafor dyslexia
  • Participants must achieve a score of 80 or more on the Full Scale IntelligenceQuotient
  • Child or adolescent participants 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 & all related tests
  • Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/ordyslexia
  • Participants for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient

Exclusion

Exclusion Criteria:

  • Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
  • Participants with severe allergies to more than 1 class of medications or who have hadmultiple adverse drug reactions
  • Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
  • Participants with documented history of autism, Asperger's syndrome, or pervasivedevelopmental disorder
  • Females who are pregnant or breastfeeding
  • Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for atleast 4 to 6 weeks

Study Design

Total Participants: 110
Study Start date:
September 01, 2008
Estimated Completion Date:
July 31, 2016

Study Description

This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in participants with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of participants with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects & effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.

Connect with a study center

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

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