Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

September 25, 2023 updated by: University of Nebraska

Pharmacological Treatment of ADHD in Young Children

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Strattera
Behavioral: Parent Training
All children will receive parent training for the duration of the study.
Other Names:
  • 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
Behavioral: Parent Training
All children will receive parent training for the duration of the study.
Other Names:
  • Psychosocial and educational intervention
Drug: Placebo
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
Other Names:
  • Pill placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total ADHD-IV Teacher
Time Frame: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.
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.
Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Christopher J Kratochvil, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimated)

November 16, 2005

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0164-03-FB
  • K23MH066127 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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