Official Title: “A Randomized, Double Blind Comparison of the Effects of Atomoxetine Versus Placebo on Neuropsychological Outcomes Across the Day in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) by Use of a Computer Based Continuous Performance Test (cb CPT)”

This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.

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: July 2009

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.
• Drug: Placebo
  • 3 capsules of placebo have to be taken once daily in the morning, with or without food.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Computer based Continuous Performance Test (cb CPT; Qbtech AB, Sweden)
  • Time Frame: During approximately 8 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv)
  • Time Frame: During approximately 8 weeks of treatment
    Safety Issue?: No
• Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD)
  • Time Frame: During approximately 8 weeks of treatment
    Safety Issue?: No
• Weekly Ratings of Evening and Morning Behavior - Revised - Investigator Rated (WREMB-R-Inv)
  • Time Frame: During approximately 8 weeks of treatment
    Safety Issue?: No
• Safety and tolerability, as assessed by adverse events (AE)
  • Time Frame: During the complete approximately 8-week treatment period
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
• Diagnosis of ADHD
• Normal intelligence
• Able to swallow capsules

Exclusion Criteria:

• Weight less than 20 kg or more than 60 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: 12 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  

Overall Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546910

Study ID Number: 11148

ClinicalTrials.gov Identifier: NCT00546910

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

Lilly Clinical Trial Registry