Status:
COMPLETED
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Mark L. Wolraich, M.D.
Eli Lilly and Company
Conditions:
Fetal Alcohol Syndrome
Attention Deficit Disorder With Hyperactivity (ADHD)
Eligibility:
All Genders
4-11 years
Phase:
PHASE1
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00417794
Start Date
August 1 2005
End Date
April 22 2015
Last Update
April 10 2017
Active Locations (1)
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1
OU Child Study Center
Oklahoma City, Oklahoma, United States, 73117