Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

Conditions
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Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)

Intervention / Treatment
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* Drug: Strattera
* Drug: Placebo


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Atomoxetine HCL (Strattera) | Drug: Strattera<br>* 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<br>* Other names: atomoxetine HCL;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Rating Scale - IV |  | length of protocol | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention deficit hyperactivity disorder, ADHD, fetal alcohol syndrome, FAS, FASD, atomoxetine hcl