Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

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, participants 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 Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
• Drug: Placebo
  • Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine Fast Titration
  • 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
• Experimental: Atomoxetine Slow Titration
  • 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
• Placebo Comparator: Placebo
  • matching placebo daily dose taken orally

Primary Measures

• Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
  • Time Frame: 9 weeks
    Safety Issue?: No
• Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
  • Time Frame: 9 weeks
    Safety Issue?: No
• Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Impact on Family Scale (FaBel), Total Impact Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions - Severity (CGI-S): ADHD Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions - Severity (CGI-S): ODD Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
  • Time Frame: 9 weeks
    Safety Issue?: No
• Number of Participants Discontinuing Treatment
  • Time Frame: 9 weeks
    Safety Issue?: No
• Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
  • Time Frame: 9 weeks
    Safety Issue?: Yes

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 presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
• Normal intelligence
• Able to swallow capsules

Exclusion Criteria:

• Weigh less than 20 kilogram (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 (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) 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 Investigator: Eli Lilly and Company Industry

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 February 09, 2012

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