Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD

Completed · Phase 3

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

In brief

Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Key facts

Study ID

NCT00418262

Run by

University of Oklahoma

People needed

27

Starts

2005-08-01

Expected to finish

2015-04-22

Last updated by the study team

2017-07-02

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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