Expired Study
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New Haven, Connecticut 06520


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00716274


Primary Contact:

Study Director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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