Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD - Full Text View

Purpose

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 III

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder Fetal Alcohol Syndrome

Drug Information available for:

Atomoxetine Atomoxetine hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

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:	June 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator	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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417794

Contacts


Contact: Lora D Tusing, BS	405-271-5700 ext 45167	lora-tusing@ouhsc.edu

Locations


United States, Oklahoma
	OU Child Study Center	Recruiting
	Oklahoma City, Oklahoma, United States, 73117
	Contact: Lora D Tusing, BS 405-271-5700 ext 45167 lora-tusing@ouhsc.edu
	Principal Investigator: Thomas M Lock, M.D.
	Sub-Investigator: Mark L Wolraich, M.D.
	Sub-Investigator: Laura J McGuinn, M.D.

Sponsors and Collaborators

University of Oklahoma

Mark L. Wolraich, M.D.

Eli Lilly and Company

Investigators


Principal Investigator:	Thomas M. Lock, M.D.	University of Oklahoma

More Information

Responsible Party:	OU Medical Center ( Mark Wolraich, M.D. )
Study ID Numbers:	B4Z-MC-X017
First Received:	January 2, 2007
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00417794
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

attention deficit hyperactivity disorder

ADHD

fetal alcohol syndrome

FAS

FASD

atomoxetine hcl

Study placed in the following topic categories:

Alcohol-Induced Disorders

Pregnancy Complications

Fetal alcohol syndrome

Atomoxetine

Disorders of Environmental Origin

Attention Deficit and Disruptive Behavior Disorders

Dyskinesias

Signs and Symptoms

Fetal Alcohol Syndrome

Fetal Diseases

Attention Deficit Disorder with Hyperactivity

Mental Disorders

Mental Disorders Diagnosed in Childhood

Substance-Related Disorders

Neurologic Manifestations

Hyperkinesis

Alcohol-Related Disorders

Ethanol

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Syndrome

Physiological Effects of Drugs

Nervous System Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	University of Oklahoma Mark L. Wolraich, M.D. Eli Lilly and Company
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00417794