Status:
COMPLETED
Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
5-6 years
Phase:
PHASE4
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 dif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00254462
Start Date
October 1 2005
End Date
September 1 2008
Last Update
October 2 2023
Active Locations (3)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
2
New York State Psychiatric Institute
New York, New York, United States, 10032
3
Duke University Medical Center
Durham, North Carolina, United States, 27705