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

• Status: Completed
• Trial end date: 2015-04-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborators: Eli Lilly and Company; Mark L. Wolraich, M.D.
• Treatments: Atomoxetine Hydrochloride; Ethanol

Criteria

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.

• 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.