Official Title: “A Randomized, Controlled,Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning Compared With Fast Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-VI Attention-Deficit/Hyperactivity Disorder (ADHD)”

Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period , patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm)or to a transition period of 2 weeks.( fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks
• Experimental: B
  • Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks

Primary Measures

• ADHD-RS-IV Parent Version:Investigator Administered and Scored
  • Time Frame: Week 2 and week 10
    Safety Issue?: No

Secondary Measures

• Global Impression of Perceived Difficulties Rating Scale-patient
  • Time Frame: Over 10 weeks
    Safety Issue?: No
• Clinical Global Impression Severity Rating Scale
  • Time Frame: Over 14 weeks
    Safety Issue?: No
• CHIP-CE-PRF ( Child Health and Illness profile Child Edition-Parent Report Form)
  • Time Frame: Over 10 weeks
    Safety Issue?: No
• Treatment Satisfaction Preference Survey
  • Time Frame: Over 14 weeks
    Safety Issue?: No
• Vital signs: height, weight, heart rate and blood pressure
  • Time Frame: Over 14 weeks
    Safety Issue?: Yes
• Columbia Suicide Rating Scale (C-SSRS)
  • Time Frame: Over 14 weeks
    Safety Issue?: Yes
• Global Impression of Perceived Difficulties Rating Scale-parent
  • Time Frame: Over 10 weeks
    Safety Issue?: No
• Global Impression of Perceived Difficulties Rating Scale- investigator
  • Time Frame: Over 10 weeks
    Safety Issue?: No

Inclusion Criteria:

• Outpatients between 6-16 years of age
• DSM-IV diagnostic criteria for ADHD must be met
• Normal laboratory and ECG results
• Normal intelligence
• Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy

Exclusion Criteria:

• Less than 20 kg or more than 70 kg at study entry
• Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk
• Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions
• Taking of anticonvulsants,antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor
• Immediate need for stimulant discontinuation due to tolerability problems
• Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 16 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) Mon-Fri 9AM - 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) 1-317-615-4559 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00760747

Study ID Number: 12305

ClinicalTrials.gov Identifier: NCT00760747

Health Authority: Spain: Spanish Agency of Medicines