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
Results First Received: December 11, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Reading Disorder
Interventions: Drug: Atomoxetine Hydrochloride
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Period I: screening/washout (89 patients screened, 13 screen-failures;45 controls screened). Period II (Visits 2-5): patients received treatment for 4 weeks and then underwent 2-week washout period after which they crossed over to receive the alternate treatment for 4 additional weeks. Period III (Visits 6-12): optional open-label (1 country only).

Reporting Groups
  Description
Atomoxetine First, Then Placebo Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
Placebo First, Then Atomoxetine Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
Normal Control Untreated 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.
Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.

Participant Flow for 2 periods

Period 1:   Study Period II
    Atomoxetine First, Then Placebo     Placebo First, Then Atomoxetine     Normal Control     Reading Disordered Control  
STARTED     39     37     27     18  
COMPLETED     39     32     26     18  
NOT COMPLETED     0     5     1     0  
Adverse Event                 0                 1                 0                 0  
Withdrawal by Subject                 0                 3                 0                 0  
Parent/Caregiver Decision                 0                 1                 0                 0  
Entry Criteria Exclusion                 0                 0                 1                 0  

Period 2:   Study Period III
    Atomoxetine First, Then Placebo     Placebo First, Then Atomoxetine     Normal Control     Reading Disordered Control  
STARTED     14 [1]   11 [1]   0     0  
COMPLETED     9     7     0     0  
NOT COMPLETED     5     4     0     0  
Adverse Event                 1                 0                 0                 0  
Lost to Follow-up                 0                 1                 0                 0  
Parent/Caregiver Decision                 1                 0                 0                 0  
Lack of Efficacy                 3                 3                 0                 0  
[1] These are patients who continued in optional open-label period (1 country). All received atomoxetine



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Atomoxetine First, Then Placebo Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
Placebo First, Then Atomoxetine Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
Normal Control Untreated 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.
Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Total Total of all reporting groups

Baseline Measures
    Atomoxetine First, Then Placebo     Placebo First, Then Atomoxetine     Normal Control     Reading Disordered Control     Total  
Number of Participants  
[units: participants]
  39     37     27     18     121  
Age  
[units: years]
Mean ± Standard Deviation
  10.0  ± 1.34     9.9  ± 1.25     9.9  ± 1.01     10.6  ± 0.99     10.0  ± 1.2  
Gender  
[units: participants]
         
Female     13     10     10     5     38  
Male     26     27     17     13     83  
Region of Enrollment  
[units: participants]
         
Belgium     18     15     0     16     49  
Netherlands     21     22     27     2     72  
Study Arm - Diagnosis  
[units: participants]
         
ADHD-Combined Type     13     15     0     0     28  
Reading Disorder     11     12     0     18     41  
ADHD-Combined Type + Reading Disorder     15     10     0     0     25  
No Disorder     0     0     27     0     27  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Lexical Decision Task Mean Reaction Time: Correct Words   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

5.  Secondary:   Lexical Decision Task Mean Reaction Time: Pseudo Words   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

6.  Secondary:   Working Memory by Corsi Block Tapping Test (CBTT)   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale   [ Time Frame: 4 week therapy endpoint ]

12.  Secondary:   Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale   [ Time Frame: 4 week therapy endpoint ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191906     History of Changes
Other Study ID Numbers: 7955, B4Z-MC-LYCK
Study First Received: September 12, 2005
Results First Received: December 11, 2008
Last Updated: May 17, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)