A Phase 3 interventional study of atomoxetine hydrochloride and placebo in Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, sponsored by Eli Lilly and Company. Completed at 16 sites in 8 countries. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-31.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 226 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
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Exclusion Criteria:
Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year
Drug: atomoxetine hydrochloride
Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year
Drug: placebo
Also known as: LY139603, Strattera
Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
Time frame: over 8 weeks
Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo
Time frame: over 8 weeks
Mean change in ratings on the Oppositional subscale of the SNAP-IV
Time frame: over 8 weeks
Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.
Time frame: over 4 weeks
Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).
Time frame: over 8 weeks
Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).
Time frame: over 8 weeks
Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).
Time frame: 8 weeks, 12 weeks
Adverse events (AEs)
Time frame: over 1 year
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company