Text Size

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00254462
First received: November 14, 2005
Last updated: August 28, 2008
Last verified: August 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment of ADHD in Young Children

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1 Drug: Atomoxetine
Participants will receive atomoxetine for 8 weeks.
Other Name: Strattera
Behavioral: Parent Training
All children will receive parent training for the duration of the study.
Placebo Comparator: 2 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: Christopher J. Kratochvil, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00254462     History of Changes
Other Study ID Numbers: K23 MH66127, DDTR BK-TKND
Study First Received: November 14, 2005
Last Updated: August 28, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013