View Clinical Trial (Medical Research Study)
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
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06520 |
| Conditions: |
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Attention Deficit Hyperactivity Disorder - Dyslexia |
| Purpose: |
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This study will evaluate the effects of atomoxetine on brain activation during attention and
reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16
years old with ADHD and comorbid dyslexia
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| Study Summary: |
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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 patients with ADHD and comorbid dyslexia.
Similar assessments are performed in two additional groups of patients 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.
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| Criteria: |
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Inclusion Criteria:
- Patients must meet DSM-IV-TR criteria for ADHD
- Patient must meet DSM-IV-TR criteria for dyslexia
- Patients must achieve a score of 80 or more on the Full Scale Intelligence
Quotient
- Child or adolescent patients 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
- Subjects for healthy control group do not meet DSM-IV-TR criteria for AHHD and/or
dyslexia
- Subjects for healthy control group must achieve a score of at least 80 but not >120
on the Full Scale Intelligence Quotient
Exclusion Criteria:
- Patients who weigh less than 25 kg or greater than 70 kg
- Patients with severe allergies to more than 1 class of medications or who have had
multiple adverse drug reactions
- Patients with prior diagnosis of bipolar I or bipolar II disorder or psychosis
- Patients with documented history of autism, Asperger's syndrome, or pervasive
developmental disorder
- Females who are pregnant or breastfeeding
- Patients treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least
4 to 6 weeks
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| NCT ID: |
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NCT00716274 |
| Primary Contact: |
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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
There is only one site for this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06520
United States
Eli Lilly
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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