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Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191906
  Purpose

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type ADHD, patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Reading Disorder
Drug: Atomoxetine Hydrochloride
Drug: placebo
Phase IV

ChemIDplus related topics:   Atomoxetine    Atomoxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • After 4 weeks of therapy, improvement in speed of inhibition as shown by a statistically significant shorter Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm.

Secondary Outcome Measures:
  • After 4 weeks of therapy, in subset of patients 10 years or older, compare performance on SSRT and a phonological task.
  • After 4 weeks of therapy, compare performance between groups on SSRT and lexical decision task.
  • After 4 weeks of therapy, compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task.
  • After 4 weeks of therapy, compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls.

Estimated Enrollment:   80
Study Start Date:   April 2005
Study Completion Date:   December 2007
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder

Exclusion Criteria:

  • Patients with Conduct Disorder
  • Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
  • Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191906

Locations
Belgium
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.    
      Gent, Belgium, 9000
Netherlands
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.    
      Amsterdam, Netherlands, 1081 BT
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.    
      Almere, Netherlands, 1311 RL
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.    
      Breda, Netherlands, 4819 EV
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.    
      Vught, Netherlands, 5260 GB

Sponsors and Collaborators
Eli Lilly and Company

Investigators
Study Director:     Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 . Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)     Eli Lilly and Company    
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   7955, B4Z-MC-LYCK
First Received:   September 12, 2005
Last Updated:   January 9, 2008
ClinicalTrials.gov Identifier:   NCT00191906
Health Authority:   Belgium: Directorate general for the protection of Public health: Medicines;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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 September 05, 2008




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