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Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Parent Training
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Atomoxetine

Eligibility Criteria

5 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center
  • New York State Psychiatric Institute
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

atomoxetine and parent training

placebo and parent training

Arm Description

atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks

matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks

Outcomes

Primary Outcome Measures

Change in ADHD-IV Rating Scale Total Score
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
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.

Full Information

First Posted
November 14, 2005
Last Updated
September 25, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00254462
Brief Title
Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Official Title
Pharmacological Treatment of ADHD in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2005 (Actual)
Primary Completion Date
August 1, 2008 (Actual)
Study Completion Date
September 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Atomoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atomoxetine and parent training
Arm Type
Experimental
Arm Description
atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
Arm Title
placebo and parent training
Arm Type
Placebo Comparator
Arm Description
matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Pill placebo
Intervention Description
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Other Intervention Name(s)
Psychosocial and educational intervention
Intervention Description
All children will receive parent training for the duration of the study.
Primary Outcome Measure Information:
Title
Change in ADHD-IV Rating Scale Total Score
Description
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.
Time Frame
Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Secondary Outcome Measure Information:
Title
Change in Total ADHD-IV Teacher
Description
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.
Time Frame
Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Kratochvil, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21422081
Citation
Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, Lubberstedt BD, Murray DW, Chrisman AK, Faircloth MA, Itchon-Ramos NB, Kollins SH, Maayan LA, Greenhill LL, Kotler LA, Fried J, March JS. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011 Apr;127(4):e862-8. doi: 10.1542/peds.2010-0825. Epub 2011 Mar 21.
Results Reference
result

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Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

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