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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD

• Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia

• Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient

• 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/or dyslexia

• Participants for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient

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 had multiple 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 pervasive developmental disorder

• Females who are pregnant or breastfeeding

• Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks