Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Atomoxetine Hydrochloride

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