Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
• Interventions: Drug: atomoxetine hydrochloride; Drug: placebo

• Registration Number: NCT00191698
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-11
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-29
• Last Update Posted: 2008-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	atomoxetine hydrochloride	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
B	placebo	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

Primary Outcome Measures

Name	Time	Method
Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo	over 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Edinburgh, United Kingdom