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

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.

Primary:

• ADHD-IV Rating Scale total score Measured at Week 8 No

Secondary:

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

Lead Sponsor: National Institute of Mental Health (NIMH)

University of Nebraska Medical Center

Omaha Nebraska 68198 United States

New York State Psychiatric Institute

New York New York 10032 United States

Duke University Medical Center

Durham North Carolina 27705 United States

Overall Clinical Trial Officials and Contacts

Christopher J. Kratochvil, MD Principal Investigator University of Nebraska  

Overall Contact: Brigette S. Vaughan, APRN 402-354-6884 bvaughan@unmc.edu

Information obtained from ClinicalTrials.gov on July 23, 2008

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