Phase 4 N=93 Randomized Double-blind Treatment

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Attention Deficit Disorder With Hyperactivity

Bottom Line

View on ClinicalTrials.gov: NCT00254462 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Change in ADHD-IV Rating Scale Total Score — -13.2; -5.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atomoxetine (Drug); Placebo (Drug); Parent Training (Behavioral)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in ADHD-IV Rating Scale Total Score	-13.2; -5.8	—
SECONDARY Change in Total ADHD-IV Teacher	-12.5; -5.0	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00254462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.