Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2005

Intervention(s) in this Clinical Trial

• Drug: atomoxetine hydrochloride
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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
• Placebo Comparator: 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

Primary Measures

• Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
  • Time Frame: over 8 weeks
    Safety Issue?: No

Secondary Measures

• Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo
  • Time Frame: over 8 weeks
    Safety Issue?: No
• Mean change in ratings on the Oppositional subscale of the SNAP-IV
  • Time Frame: over 8 weeks
    Safety Issue?: No
• 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
    Safety Issue?: No
• Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).
  • Time Frame: over 8 weeks
    Safety Issue?: No
• Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).
  • Time Frame: over 8 weeks
    Safety Issue?: No
• Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).
  • Time Frame: 8 weeks, 12 weeks
    Safety Issue?: No
• Adverse events (AEs)
  • Time Frame: over 1 year
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00191698

Study ID Number: 7068

ClinicalTrials.gov Identifier: NCT00191698

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Lilly Clinical Trial Registry