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Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD) (ADHD SWITCH)
This study is currently recruiting participants.
Verified by Eli Lilly and Company, December 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00760747
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: Atomoxetine
 Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
Drug Information available for: Atomoxetine Atomoxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • ADHD-RS-IV Parent Version:Investigator Administered and Scored [ Time Frame: Week 2 and week 10 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
Drug: Atomoxetine
B: Experimental
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
Drug: Atomoxetine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760747

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

Locations
Australia, New South Wales
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Concord West, New South Wales, Australia, 2138
Contact: Eli Lilly            
Australia, Queensland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Milton, Queensland, Australia, 4064
Contact: Eli Lilly            
Australia, Victoria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Parkville, Victoria, Australia, 3052
Contact: Eli Lilly            
Portugal
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Coimbra, Portugal, 3000-076
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Lisbon, Portugal, 1495
Contact: Eli Lilly            
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Palma De Mallorca, Spain, 07198
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Sabadell, Spain, 08208
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
San Sebastian, Spain, 20009
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Valencia, Spain, 46009
Contact: Eli Lilly            
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Northampton, United Kingdom, NN1 2BG
Contact: Eli Lilly            
United Kingdom, Lancashire
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Wigan, Lancashire, United Kingdom, WN2 2JA
Contact: Eli Lilly            
United Kingdom, Northern Ireland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Belfast, Northern Ireland, United Kingdom, BT16 0TH
Contact: Eli Lilly            
United Kingdom, Scotland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Fife, Scotland, United Kingdom, KY2 5AH
Contact: Eli Lilly            
United Kingdom, South Yorkshire
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 5DD
Contact: Eli Lilly            
United Kingdom, West Midlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Birmingham, West Midlands, United Kingdom, B13 8QE
Contact: Eli Lilly            
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 12305, B4Z-EW-LYFJ
Study First Received: September 25, 2008
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00760747  
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Eli Lilly and Company:
ADHD
Children
Stimulant
Atomoxetine
Adolescents

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine
 Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
 Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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