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| Name | Class |
|---|---|
| Mark L. Wolraich, M.D. | UNKNOWN |
| Eli Lilly and Company | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Atomoxetine HCL (Strattera) |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strattera | Drug | escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale - IV | length of protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if atomoxetine is safe and well tolerated by children with FAS. | length of protocol | |
| Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura J McGuinn, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Child Study Center | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast. |
|
| length of protocol |
| Determine if atomoxetine improves behaviors in the mornings and evenings. | Length of protocol |
| Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine. | Length of protocol |
| Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine. | Length of protocol |
| Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI) | Length of protocol |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |