Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD (B4Z-MC-X017)

This study is ongoing, but not recruiting participants.
Mark L. Wolraich, M.D.
Eli Lilly and Company
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: January 2, 2007
Last updated: December 2, 2014
Last verified: December 2014
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.

Condition Intervention Phase
Fetal Alcohol Syndrome
Attention Deficit Disorder With Hyperactivity (ADHD)
Attention Deficit Disorder (ADD)
Drug: Strattera
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • ADHD Rating Scale - IV [ Time Frame: length of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine if atomoxetine is safe and well tolerated by children with FAS. [ Time Frame: length of protocol ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine if atomoxetine improves behaviors in the mornings and evenings. [ Time Frame: Length of protocol ] [ Designated as safety issue: No ]
  • Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine. [ Time Frame: Length of protocol ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atomoxetine HCL (Strattera)
Drug: Strattera
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
Other Name: atomoxetine HCL
Placebo Comparator: 2 Drug: Placebo
0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Detailed 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.

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00417794

United States, Oklahoma
OU Child Study Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Mark L. Wolraich, M.D.
Eli Lilly and Company
Principal Investigator: Laura J McGuinn, PhD University of Oklahoma
  More Information

Responsible Party: University of Oklahoma Identifier: NCT00417794     History of Changes
Other Study ID Numbers: 2115 
Study First Received: January 2, 2007
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
attention deficit hyperactivity disorder
fetal alcohol syndrome
atomoxetine hcl

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Fetal Alcohol Spectrum Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Chemically-Induced Disorders
Fetal Diseases
Mental Disorders
Nervous System Diseases
Neurodevelopmental Disorders
Neurologic Manifestations
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Substance-Related Disorders
Atomoxetine Hydrochloride
Adrenergic Agents
Adrenergic Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs processed this record on May 24, 2016