Effects of Atomoxetine on Brain Activation During Attention and Reading Tasks in Patients With ADHD & Comorbid Dyslexia - NCT00716274-06520 (Clinical Trial 231094)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy231094.aspx
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| City: |
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New Haven |
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State:
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CT |
| 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. |
| 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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| Study is available at: |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Haven, CT 06520
United States
Primary Contact:
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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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