Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD (NCT00417794) | Clinical Trial Compass
CompletedPhase 1
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
United States38 participantsStarted 2005-08
Plain-language 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.
Who can participate
Age range4 Years – 11 Years
SexALL
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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.…