Status:
COMPLETED
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Dyslexia
Eligibility:
All Genders
10-16 years
Phase:
PHASE4
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00716274
Start Date
September 1 2008
End Date
July 1 2016
Last Update
November 4 2022
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520