Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Attention Deficit Disorder With Hyperactivity
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Atomoxetine
Eligibility 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
Sites / Locations
- University of Nebraska Medical Center
- New York State Psychiatric Institute
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
atomoxetine and parent training
placebo and parent training
atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks