Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191906
First received: September 12, 2005
Last updated: May 17, 2010
Last verified: May 2010

September 12, 2005
May 17, 2010
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: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.
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
  • Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.
  • Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.
  • Lexical Decision Task Mean Reaction Time: Correct Words [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.
  • Lexical Decision Task Mean Reaction Time: Pseudo Words [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.
  • Working Memory by Corsi Block Tapping Test (CBTT) [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ] [ Designated as safety issue: No ]
    Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale [ Time Frame: 4 week therapy endpoint ] [ Designated as safety issue: No ]
    Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale [ Time Frame: 4 week therapy endpoint ] [ Designated as safety issue: No ]
    Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
  • Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.
  • Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.
  • Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.
  • Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words [ Time Frame: Baseline and 4 weeks of therapy ] [ Designated as safety issue: No ]
    Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.
  • 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.
Not Provided
Not Provided
 
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
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 Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Reading Disorder
  • Drug: Atomoxetine Hydrochloride
    Atomoxetine, 1.2 mg/kg/day, by mouth (PO)
    Other Names:
    • LY139603
    • Strattera
  • Drug: placebo
    Placebo, every day (QD), by mouth (PO)
  • Experimental: Atomoxetine first, then Placebo
    Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks
    Interventions:
    • Drug: Atomoxetine Hydrochloride
    • Drug: placebo
  • Experimental: Placebo first, then Atomoxetine
    Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks
    Interventions:
    • Drug: Atomoxetine Hydrochloride
    • Drug: placebo
  • No Intervention: Normal Control
    Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
  • No Intervention: Reading Disordered Control
    The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.
de Jong CG, Van De Voorde S, Roeyers H, Raymaekers R, Allen AJ, Knijff S, Verhelst H, Temmink AH, Smit LM, Rodriques-Pereira R, Vandenberghe D, van Welsen I, ter Schuren L, Al-Hakim M, Amin A, Vlasveld L, Oosterlaan J, Sergeant JA. Differential effects of atomoxetine on executive functioning and lexical decision in attention-deficit/hyperactivity disorder and reading disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):699-707. doi: 10.1089/cap.2009.0029.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
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
7955, B4Z-MC-LYCK
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
May 2010

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