Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • Participants will receive atomoxetine for 8 weeks.
• Drug: Placebo
  • Participants will receive placebo for 8 weeks.
• Behavioral: Parent Training
  • All children will receive parent training for the duration of the study.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• ADHD-IV Rating Scale total score
  • Time Frame: Measured at Week 8
    Safety Issue?: No

Secondary Measures

• Conners Parent Rating Scale & Conners Teacher Rating Scale
  • Time Frame: Measured at Week 8
    Safety Issue?: No
• ADHD-IV Teacher
  • Time Frame: Measured at Week 8
    Safety Issue?: No
• CGI-I and CGI-S and CGAS
  • Time Frame: Measured at Week 8
    Safety Issue?: No
• Emotional Expression Scale for Children
  • Time Frame: Measured at Week 8
    Safety Issue?: No
• Parent Stress Index
  • Time Frame: Measured at Week 8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Christopher J. Kratochvil, MD Principal Investigator University of Nebraska  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00254462

Study ID Number: K23 MH66127

ClinicalTrials.gov Identifier: NCT00254462

Health Authority: United States: Federal Government