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

Fetal Alcohol Syndrome Clinical Trial

— B4Z-MC-X017  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417794
• Other study ID #: 2115
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2007
• Last updated: April 6, 2017
• Start date: August 2005
• Est. completion date: April 22, 2015

Study information

• Verified date: April 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 22, 2015
• Est. primary completion date: April 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder (ADD)
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorder With Hyperactivity (ADHD)
• Disease
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Hyperkinesis
• Syndrome

Intervention

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
• Placebo
0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Locations

Country	Name	City	State
United States	OU Child Study Center	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Eli Lilly and Company, Mark L. Wolraich, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Rating Scale - IV		length of protocol
Secondary	Determine if atomoxetine is safe and well tolerated by children with FAS.		length of protocol
Secondary	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
Secondary	Determine if atomoxetine improves behaviors in the mornings and evenings.		Length of protocol
Secondary	Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.		Length of protocol
Secondary	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
Secondary	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