Clinical trial NCT00254462: Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Official title: Pharmacological Treatment of ADHD in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Atomoxetine
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-11-16
Enrollment: 93
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Change in ADHD-IV Rating Scale Total Score
timeFrame: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Secondary outcomes:
measure: Change in Total ADHD-IV Teacher
timeFrame: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of Nebraska
name: Christopher J Kratochvil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, Lubberstedt BD, Murray DW, Chrisman AK, Faircloth MA, Itchon-Ramos NB, Kollins SH, Maayan LA, Greenhill LL, Kotler LA, Fried J, March JS. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011 Apr;127(4):e862-8. doi: 10.1542/peds.2010-0825. Epub 2011 Mar 21.