NCT00716274

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

Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Attention Deficit Hyperactivity Disorder
• Dyslexia

Interventions

Type	Name	Description
DRUG	Atomoxetine	Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
DRUG	Placebo	oral, daily, for 16 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2008-07-16
• Last updated: 2022-11-04
• Results posted: 2018-02-07

Locations

1 site across 1 country: United States