Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Pharmacological Treatment of ADHD in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254462
• Other study ID #: 0164-03-FB
• Secondary ID: K23MH066127
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2005
• Est. completion date: September 1, 2008

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 1, 2008
• Est. primary completion date: August 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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.
• Placebo
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.

Behavioral:
• Parent Training
All children will receive parent training for the duration of the study.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	New York State Psychiatric Institute	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Secondary	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.	Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.