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

A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD); Fetal Alcohol Syndrome
• Intervention / Treatment: Drug: Strattera; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • OU Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: atomoxetine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ADHD Rating Scale - IV	length of protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine if atomoxetine is safe and well tolerated by children with FAS.	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.	length of protocol
Determine if atomoxetine improves behaviors in the mornings and evenings.	Length of protocol
Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.	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.	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)	Length of protocol

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Eli Lilly and Company; Mark L. Wolraich, M.D.
• Investigators: Principal Investigator: Laura J McGuinn, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): April 22, 2015
• Study Completion (Actual): April 22, 2015

Study Registration Dates

• First Submitted: January 2, 2007
• First Submitted That Met QC Criteria: January 3, 2007
• First Posted (Estimate): January 4, 2007

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ADHD; attention deficit hyperactivity disorder; FAS; FASD; fetal alcohol syndrome; atomoxetine hcl
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Neurologic Manifestations; Dyskinesias; Fetal Diseases; Pregnancy Complications; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Alcohol-Induced Disorders; Syndrome; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Fetal Alcohol Spectrum Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 2115