This trial is active, not recruiting.

Conditions fetal alcohol syndrome, attention deficit disorder with hyperactivity (adhd), attention deficit disorder (add)
Treatments strattera, placebo
Phase phase 3
Sponsor University of Oklahoma
Collaborator Mark L. Wolraich, M.D.
Start date August 2005
End date July 2015
Trial size 60 participants
Trial identifier NCT00417794, 2115


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Atomoxetine HCL (Strattera)
strattera atomoxetine HCL
escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy
(Placebo Comparator)
0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Primary Outcomes

ADHD Rating Scale - IV
time frame: length of protocol

Secondary Outcomes

Determine if atomoxetine is safe and well tolerated by children with FAS.
time frame: length of protocol
Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.
time frame: length of protocol
Determine if atomoxetine improves behaviors in the mornings and evenings.
time frame: Length of protocol
Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.
time frame: Length of protocol
Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.
time frame: Length of protocol
Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)
time frame: Length of protocol

Eligibility Criteria

Male or female participants from 4 years up to 11 years old.

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.

Additional Information

Official title A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects
Principal investigator Laura J McGuinn, PhD
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 studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Oklahoma.