Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00254462

Purpose

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Atomoxetine Drug: Placebo Behavioral: Parent Training	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pharmacological Treatment of ADHD in Young Children

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

ADHD-IV Rating Scale total score [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conners Parent Rating Scale & Conners Teacher Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
ADHD-IV Teacher [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
CGI-I and CGI-S and CGAS [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Emotional Expression Scale for Children [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Parent Stress Index [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	October 2005
Estimated Study Completion Date:	February 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Atomoxetine Participants will receive atomoxetine for 8 weeks. Behavioral: Parent Training All children will receive parent training for the duration of the study.
2: Placebo Comparator	Drug: Placebo Participants will receive placebo for 8 weeks. Behavioral: Parent Training All children will receive parent training for the duration of the study.

Detailed Description:

Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.

Eligibility

Ages Eligible for Study:	5 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Parent and child must be English speaking
Child has been living with parent/guardian for at least six months
Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus conference
ADHD is primary disorder with symptoms present for at least 9 months
ADHD-IV-RS score that is at least 1.5 standard deviations above age and sex norms
Score of 55 or below on the Children's Global Assessment Scale
Score of 4 or greater on the Clinical Global Impression Scale
Estimated IQ of 70 or greater
Currently participating in school at least 2 half-days per week
Able to identify a teacher who can make valid assessments
Patient and parent are able to attend regular study visits

Exclusion Criteria:

Currently taking other psychotropic medications or other medications with effects on the central nervous system
Currently being treated effectively with atomoxetine
Major medical conditions that might interfere with study medications
History of or current clinically significant kidney illness
Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide ideations, or any other psychiatric disorder requiring treatment with additional psychotropic medication
History of physical, sexual, or emotional abuse impacting clinical presentation
Prior failure to respond to an adequate trial of atomoxetine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254462

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Christopher J. Kratochvil, MD

University of Nebraska

More Information

No publications provided

Responsible Party:	University of Nebraska Medical Center ( Christopher J. Kratochvil, MD )
Study ID Numbers:	K23 MH66127, DDTR BK-TKND
Study First Received:	November 14, 2005
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00254462 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

ADHD
Atomoxetine

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009