Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christopher J. Kratochvil, M.D., University of Nebraska
ClinicalTrials.gov Identifier:
NCT00254462
First received: November 14, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Change in ADHD-IV Rating Scale Total Score [ Time Frame: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint. ] [ Designated as safety issue: No ]

    Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.

    The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27.



Secondary Outcome Measures:
  • Change in Total ADHD-IV Teacher [ Time Frame: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point. ] [ Designated as safety issue: No ]
    Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.


Enrollment: 93
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: atomoxetine and parent training
atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
Drug: Atomoxetine
Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
Other Name: Strattera
Behavioral: Parent Training
All children will receive parent training for the duration of the study.
Other Name: Psychosocial and educational intervention
Placebo Comparator: placebo and parent training
matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
Drug: Placebo
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
Other Name: Pill placebo
Behavioral: Parent Training
All children will receive parent training for the duration of the study.
Other Name: Psychosocial and educational intervention

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-Rating Scale (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 Intelligence Quotient (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Nebraska
Investigators
Principal Investigator: Christopher J. Kratochvil, MD University of Nebraska
  More Information

Publications:
Responsible Party: Christopher J. Kratochvil, M.D., Professor Psychiatry and Pediatrics, University of Nebraska
ClinicalTrials.gov Identifier: NCT00254462     History of Changes
Other Study ID Numbers: K23 MH66127, K23MH066127
Study First Received: November 14, 2005
Results First Received: October 3, 2011
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Nebraska:
ADHD
Atomoxetine

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
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 September 29, 2014