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Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

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ClinicalTrials.gov Identifier: NCT00607919
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : December 15, 2011
Last Update Posted : December 15, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Dyslexia
Interventions: Drug: Atomoxetine
Drug: Placebo

  Participant Flow

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
The study comprised a 16-week placebo-controlled, double-blind acute phase and followed by an optional 16-week open-label in which all participants were treated with Atomoxetine.

Reporting Groups
  Description
Atomoxetine/Atomoxetine

Participants were assigned to Atomoxetine treatment in both acute and open-label phase

Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Placebo/Atomoxetine

Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine


Participant Flow for 2 periods

Period 1:   Acute Phase
    Atomoxetine/Atomoxetine   Placebo/Atomoxetine
STARTED   120   89 
COMPLETED   86 [1]   73 [1] 
NOT COMPLETED   34   16 
Adverse Event                9                2 
Entry Criteria Not Met                1                1 
Lack of Efficacy                1                2 
Lost to Follow-up                9                3 
Parent/Caregiver Decision                6                4 
Protocol Violation                5                1 
Withdrawal by Subject                3                3 
[1] 2 participants completed acute phase but did not continue into open-label.

Period 2:   Open-Label Phase
    Atomoxetine/Atomoxetine   Placebo/Atomoxetine
STARTED   84   71 
COMPLETED   74   59 
NOT COMPLETED   10   12 
Adverse Event                1                5 
Lost to Follow-up                4                1 
Protocol Violation                2                2 
Withdrawal by Subject                2                2 
Parent/Caregiver Decision                1                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Atomoxetine/Atomoxetine

Participants were assigned to Atomoxetine treatment in both acute and open-label phase

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Placebo/Atomoxetine

Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Total Total of all reporting groups

Baseline Measures
   Atomoxetine/Atomoxetine   Placebo/Atomoxetine   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   89   209 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.24  (1.72)   12.44  (1.90)   12.32  (1.80) 
Gender 
[Units: Participants]
     
Female   46   34   80 
Male   74   55   129 
Race/Ethnicity, Customized 
[Units: Participants]
     
African   13   11   24 
Caucasian   86   66   152 
East Asian   2   1   3 
Hispanic   18   11   29 
West Asian   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   120   89   209 


  Outcome Measures

1.  Primary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

2.  Secondary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

3.  Secondary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

4.  Secondary:   Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

5.  Secondary:   Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

6.  Secondary:   Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

7.  Secondary:   Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

8.  Secondary:   Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

9.  Secondary:   Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

10.  Secondary:   Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

11.  Secondary:   Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint   [ Time Frame: Baseline, 16 weeks ]

12.  Secondary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

13.  Secondary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

14.  Secondary:   Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

15.  Secondary:   Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

16.  Secondary:   Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

17.  Secondary:   Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

18.  Secondary:   Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

19.  Secondary:   Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

20.  Secondary:   Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]

21.  Secondary:   Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint   [ Time Frame: Baseline, 32 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00607919     History of Changes
Other Study ID Numbers: 11672
B4Z-US-LYEB ( Other Identifier: Eli Lilly and Company )
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: November 11, 2011
Results First Posted: December 15, 2011
Last Update Posted: December 15, 2011