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

Completed · Phase 1 · Has a placebo group

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

In brief

The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.

Key facts

Study ID

NCT00417794

Run by

University of Oklahoma

People needed

38

Starts

2005-08-01

Expected to finish

2015-04-22

Last updated by the study team

2017-04-10

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OU Child Study Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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