Phase 4
Completed N=93
Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00254462 ↗
Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Change in ADHD-IV Rating Scale Total Score — -13.2; -5.8 units on a scale
Summary
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
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 | — |
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
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. Informational only — not medical advice.