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

NCT00417794 | Completed Phase 1 DMC

• 1 other identifier: 2115
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Alcohol Syndrome; Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)

Keywords

attention deficit hyperactivity disorder; ADHD; fetal alcohol syndrome; FAS; FASD; atomoxetine hcl

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale - IV

  length of protocol

Secondary Outcomes (6)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Atomoxetine HCL (Strattera)

Drug: Strattera

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Strattera DRUG

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

Also known as: atomoxetine HCL

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Mark L. Wolraich, M.D.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

OU Child Study Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Laura J McGuinn, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: August 1, 2005
• Primary Completion: April 22, 2015
• Study Completion: April 22, 2015
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)