View Clinical Trial (Medical Research Study)
A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects
| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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73117 |
| Conditions: |
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Fetal Alcohol Syndrome - Attention Deficit Disorder With Hyperactivity (ADHD) - Attention Deficit Disorder (ADD) |
| Purpose: |
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The purpose of this study is to determine if atomoxetine hydrochloride improves inattention,
hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
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| Study Summary: |
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Abnormalities of attention, function, and activity level in children exposed to alcohol in
utero share similarities and differences to children who do not have alcohol exposure.
Previous psychological studies have examined either core attention deficit hyperactivity
disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized
neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD.
Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will
determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with
fetal alcohol exposure.
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| Criteria: |
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Inclusion Criteria:
- Patient must be between the ages of 4 and 11 years at the time of entry into the
study.
- Patients must meet diagnostic criteria for FASD
- Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV
score of > or = to 90%ile for age and gender for either subtest or total score if
greater than 5 years of age.
- Patients who enter the study at visit 1 taking stimulant medication must be
medication-free for at least 24 hours before visit 2.
- History and physical exam must reveal no clinically significant abnormalities that
would preclude safe participation in the study.
- Patients must be able to swallow capsules.
- Patients must be of a sufficient developmental level (~3 yrs) to participate in the
study.
- Patients and parents must be able to communicate effectively with the investigator
and coordinator and be judged reliable to keep appointments and participate in data
collection.
- Teacher must agree to cooperate with the study. Children less than 6 years old must
have completed a course of PCIT and still meet DSM-IV criteria for ADHD.
Exclusion Criteria:
- Have received an in investigational medication in the past 30 days.
- Are currently on a medication treatment that is effective (ADHDRS-IV score within 1
SD of average) and well tolerated.
- Have significant current medical conditions that could be exacerbated or compromised
by atomoxetine.
- Have used MAOIs within one month prior to visit 2.
- Patients with hypertension.
- Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum
disorder.
- Patients taking anticonvulsants for seizure control.
- Patients taking another psychotropic medication or health food supplements purported
to have central nervous system activity within 5 half-lives of visit 2.
- Patients with Tourette Disorder or any other neurological condition that would
interfere with their ability to receive treatment or comply with monitoring.
- Pubertal girls.
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| NCT ID: |
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NCT00417794 |
| Primary Contact: |
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Principal Investigator
Thomas M. Lock, M.D.
University of Oklahoma
Lora D Tusing, BS, RN
Phone: 405-271-5700 ext. 45167
Email: lora-tusing@ouhsc.edu
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| Backup Contact: |
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Email: brenda-schlinke@ouhsc.edu
Brenda Schlinke, R.N.
Phone: 405-271-5700 ext. 45167
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| Location Contact: |
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Oklahoma City, Oklahoma 73117
United States
Lora D Tusing, BS, RN
Phone: 405-271-5700
Email: lora-tusing@ouhsc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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