Status:
COMPLETED
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Mark L. Wolraich
Conditions:
Fetal Alcohol Syndrome
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief Summary
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
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 have been between the ages of 4 and 11 years at the time of entry into the double blind study.
- Patients must meet diagnostic criteria for FASD.
- Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of \> or + 90% for age and gender on either subtest or total score for children above 5 years of age.
- Patients will continue atomoxetine/placebo until entry nto this study.
- 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 mental age (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.
Exclusion
- Have received an investigational medication other than atomoxetine in the previous 30 days.
- Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
- Have used MAOIs within one month prior to visit 1.
- 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 1.
- 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 :
27 Patients enrolled
Trial Details
Trial ID
NCT00418262
Start Date
August 1 2005
End Date
April 22 2015
Last Update
July 2 2017
Active Locations (1)
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1
OU Child Study Center
Oklahoma City, Oklahoma, United States, 73117