Official Title: “A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder”

A three-arm, randomized, double-blind, placebo-controlled Phase 4 multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD) and comorbid Oppositional Defiant Disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the SNAP-IV ODD subscale score.

Study Type: Interventional

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

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
• Drug: Placebo
  • QD, PO for 9 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • 0.5 mg/kg/day QD, PO for 1 week then 1.2 mg/kg/day QD, PO for 8 weeks
• Experimental: B
  • 0.5 mg/kg/day QD, PO for 1 week then 0.8 mg/kg/day QD, PO for 1 week then 1.2 mg/kg/day QD, PO for 7 weeks
• Placebo Comparator: C

Primary Measures

• investigator-rated oppositional subscale of the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV)
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• SNAP-IV ADHD subscale scores (Inattention subscale score, Hyperactivity/Impulsivity subscale score, and combined score)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Parent Rating Scales for Attention Deficit/Hyperactivity Disorder (FBB-HKS)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Investigator-rated Individual Target Behaviors (ITB-Inv)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions-Severity of ADHD(CGI-S-ADHD)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Parent-rated quality of life questionnaire KINDL
  • Time Frame: 9 weeks
    Safety Issue?: No
• Parent-rated family burden questionnaire FaBel
  • Time Frame: 9 weeks
    Safety Issue?: No
• Time to treatment discontinuation
  • Time Frame: 9 weeks
    Safety Issue?: No
• adverse events (AEs)
  • Time Frame: 3 weeks, 9 weeks
    Safety Issue?: No
• Oppositional Defiant/Conduct Disorders (FBB-SSV)of the German Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-KJ)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions-Severity of ODD(CGI-S-ODD)
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions-Severity of ADHD and ODD combined (CGI-S-ADHD+ODD)
  • Time Frame: 9 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
• Diagnosis of ADHD and ODD
• Normal intelligence
• Able to swallow capsules

Exclusion Criteria:

• Weigh less than 20 kg or more than 90 kg at study entry
• Prior treatment with atomoxetine
• History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
• History of severe allergies or multiple adverse drug reactions
• Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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 - 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/NCT00406354

Study ID Number: 11149

ClinicalTrials.gov Identifier: NCT00406354

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Lilly Clinical Trial Registry