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Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder
This study has been completed.
Study NCT00191906   Information provided by Eli Lilly and Company
First Received: September 12, 2005   Last Updated: September 19, 2008   History of Changes

September 12, 2005
September 19, 2008
April 2005
December 2007   (final data collection date for primary outcome measure)
Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00191906 on ClinicalTrials.gov Archive Site
  • In subset of patients 10 years or older, compare performance on SSRT and a phonological task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Compare performance between groups on SSRT and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Working memory by Corsi Block Tapping Test (CBTT) [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: over 6 weeks ] [ Designated as safety issue: Yes ]
  • 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.
 
Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder
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.

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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
  • Attention Deficit Hyperactivity Disorder
  • Reading Disorder
  • Drug: Atomoxetine Hydrochloride
  • Drug: placebo
  • Experimental: Atomoxetine, 1.2 mg/kg/day, PO for 4 weeks, 2 week washout period and cross-over to placebo, QD, PO for 4 weeks
  • Experimental: Placebo, QD, PO for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
76
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
NCT00191906
Chief Medical Officer, Eli Lilly
7955, B4Z-MC-LYCK
Eli Lilly and Company
 
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
Eli Lilly and Company
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP