Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

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.

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: Atomoxetine
  • 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
• Placebo Comparator: Placebo
  • Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine

Primary Measures

• Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
  • Time Frame: Baseline, 8 weeks (W8)
    Safety Issue?: No
• Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No

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 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/NCT00546910

Study ID Number: 11148

ClinicalTrials.gov Identifier: NCT00546910

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

Lilly Clinical Trial Registry