A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Eli Lilly and Company1 site in 1 country226 target enrollmentDecember 2003

ConditionsAttention Deficit Hyperactivity Disorder Oppositional Defiant Disorder

Interventionsatomoxetine hydrochloride placebo

Drugsatomoxetine hydrochloride placebo

Overview

Phase: Phase 3
Intervention: atomoxetine hydrochloride
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 226
Locations: 1
Primary Endpoint: Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

November 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
•Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
•If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
•Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
•Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.

Exclusion Criteria

•Patients who weigh less than 20 kg or greater than 60 kg at study entry.
•Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
•Patients who have a current diagnosis of Major Depressive Disorder (\[MDD\]; with or without psychotic features), PTSD, or CDRS-R total raw score \>40 at study entry.
•Patients with a history of any seizure disorder.
•Patients determined by the investigator to be at serious suicidal risk.

Arms & Interventions

A

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

Intervention: atomoxetine hydrochloride

B

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

Intervention: placebo

Outcomes

Primary Outcomes

Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo

Time Frame: over 8 weeks

Secondary Outcomes

Adverse events (AEs)(over 1 year)
Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo(over 8 weeks)
Mean change in ratings on the Oppositional subscale of the SNAP-IV(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.(over 4 weeks)
Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).(over 8 weeks)
Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).(over 8 weeks)
Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).(8 weeks, 12 weeks)